Publications by authors named "Amelie Pielen"

47 Publications

[Epidemiology and treatment of retinopathy of prematurity. The Hannover data in the Retina.net ROP registry from 2001-2017].

Ophthalmologe 2021 Nov 22. Epub 2021 Nov 22.

Universitätsklinik für Augenheilkunde, Medizinische Hochschule Hannover, Carl-Neuberg-Str. 1, 30625, Hannover, Deutschland.

Background: The Retina.net ROP registry documents data of preterm infants developing stages of retinopathy of prematurity (ROP) that need ROP treatment. The aim of this analysis was to investigate data regarding epidemiology, therapy and changes over time (15 years) in a single participating center (Hannover Medical School, MHH).

Methods: Analysis of data of infants treated for ROP at a single center over time (birth 2001-2016, ROP treatment in 2002-2017).

Results: Overall, 65 infants were treated (23 female). In 11 infants (16.9%) ROP screening was conducted externally and infants were transferred to the MHH for ROP treatment. Between 2006 and 2016, incidence of ROP requiring treatment among infants screened for the development of ROP was 4.1%. Mean gestational age was 25.7 weeks (standard deviation, SD 1.8), mean birth weight 763 g (SD 235), postmenstrual age at treatment 38.2 weeks (SD 3.2), postnatal age 12.4 weeks (SD 3.2). There was no significant change in parameters over time. ROP zone II, stage 3+ was most frequently treated (57 eyes of 31 infants). 58 infants were treated with laser (114 eyes), 7 infants were treated with anti-VEGF (bevacizumab, bilateral, 14 eyes) from 2014 onwards. Retreatment due to recurrence of ROP was necessary in one infant after initial laser coagulation. Infants with ROP requiring treatment often presented with neonatal comorbidities, ventilation in more than 90%, bronchopulmonary dysplasia, and received transfusions.

Conclusion: This is the first monocentric analysis over 15 years originating from the Retina.net ROP registry. In this cohort we see a change in ROP therapy from laser coagulation to anti-VEGF (bevacizumab) from 2014 onwards, demographic data and treatment parameters remained relatively stable over time.
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http://dx.doi.org/10.1007/s00347-021-01528-9DOI Listing
November 2021

[Nonaretritic central retinal artery occlusion as marker for the generalized vascular risk].

Ophthalmologe 2021 Nov 4;118(11):1093-1098. Epub 2021 Aug 4.

Neurologie mit Schwerpunkt neurovaskuläre Erkrankungen, Eberhard Karls Universität Tübingen, Tübingen, Deutschland.

Background: Retinal artery occlusion (RAO) represents a limiting visual perception for affected patients. In all efforts to improve function it must not be forgotten that in the vast majority of cases the cause is one or more severe vascular or cardiac diseases, which can cause RAO just as ischemic stroke and can also be life-threatening.

Objective: The aim of this article is to present the available literature and to explain the importance of an intensive neurological internal medical clarification in RAO patients.

Conclusion: Although cardiovascular diseases are already known in most patients at the onset of an RAO, further risk factors are detected in almost 80% of cases. Therefore, and because of the high risk for recurrent thromboembolism, immediate and standardized neurological internal medical clarification of the cause is urgently recommended after an acute RAO in the context of an inpatient stay.
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http://dx.doi.org/10.1007/s00347-021-01466-6DOI Listing
November 2021

Development of a Patient-Oriented Organizational Management System for Intravitreal Injection Therapy in a Standardized "Treat-and-Extend" Regime at a University Eye Clinic.

Klin Monbl Augenheilkd 2020 Nov 26. Epub 2020 Nov 26.

Universitätsklinik für Augenheilkunde, Medizinische Hochschule Hannover, Deutschland.

Background: The treatment of macular edema with intravitreal injections has revolutionized the treatment of associated diseases in ophthalmology. However, with a few exceptions, this is a chronic treatment where patients require many injections and usually need to stay in treatment for years. Patient adherence and control of patient flow are critical to treatment success. In this manuscript, we describe the development of a patient-oriented organization management for intravitreal injections in a university hospital.

Material And Methods: In 2015, the intravitreal treatment in our clinic was switched to the treat-and-extend regime. At the same time, the optimization of the previous organizational processes in perioperative management was evaluated. For the period 2015 to 2018, we analyzed and gradually optimized the procedures of our intravitreal injection therapy in a survey with a specialized service provider.

Results: Through the analysis of the original processes, the patient appointment was optimized, work processes were summarized, spatially reorganized and there was only a slight increase in the number of staff involved compared with the significant increase in the number of injections. Through these measures, the total in-hospital-time of the patients could be drastically reduced and at the same time the number of patients on one operation day could be multiplied.

Conclusion: In the context of chronic treatment with intravitreal injections, the care of an increased number of patients is a logistical challenge. By optimizing processes, existing resources can be better used to meet the increased demands. An optimized system offers the patient greater adherence and a better visual outcome largely independent of the medication used.
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http://dx.doi.org/10.1055/a-1266-3546DOI Listing
November 2020

Selective retina therapy (SRT) in patients with therapy refractory persistent acute central serous chorioretinopathy (CSC): 3 months functional and morphological results.

Graefes Arch Clin Exp Ophthalmol 2021 Jun 18;259(6):1401-1410. Epub 2020 Nov 18.

University Eye Hospital, Medical School Hannover, Carl-Neuberg-Str.1, 30625, Hannover, Germany.

Purpose: Central serous chorioretinopathy (CSC) is a disease presenting with detachment of the neurosensory retina and characteristic focal leakage on fluorescein angiography. The spontaneous remission rate is 84% within 6 months. In this study, the efficacy of selective retina therapy (SRT) was examined in patients with therapy refractory persistent acute CSC defined by symptoms for at least 6 months and persistent subretinal fluid (SRF) despite eplerenone therapy.

Material And Methods: This is a prospective, monocentric observational study in 17 eyes (16 patients, mean age 42 years, 2 female). SRT was performed with the approved R:GEN laser (Lutronic, South Korea), a micropulsed 527-nm Nd:YLF laser device, with a train of 30 pulses of 1.7 μs at 100-Hz repetition rate at the point of focal leakage determined by fluorescein angiography (FA) at baseline (BSL). Visits on BSL, week 4 (wk4), and week 12 (wk12) included best corrected visual acuity (BCVA, logMar), central retinal thickness (CRT) on spectral domain optical coherence tomography (SD-OCT), and FA. Statistical analysis was performed by pair-by-pair comparisons of multiple observations in each case with Bonferroni correction for multiple testing. (IBM SPSS Statistics 25®).

Results: Mean CRT at BSL was 387.69 ± 110.4 μm. CRT significantly decreased by 106.31 μm in wk4 (95%-KI: 21.42-191.2; p = 0.01), by 133.63 μm in wk12 (95%-KI: 50.22-217.03; p = 0.001) and by 133.81 μm (95%-KI: 48.88-218.75; p = 0.001) compared to BSL. Treatment success defined as complete resolution of SRF occurred at wk4 in 7/17 eyes (35.3%) and at wk12 in 10/17 eyes (58.8%). Re-SRT was performed in 7/17 eyes (41.2%) after an average of 107.14 ± 96.59 days. Treatment success after Re-SRT was observed in 4/6 eyes (66.6%, 12 weeks after Re-SRT). Mean BCVA did not change significantly from BSL to any later timepoint after adjusting for multiple testing. Notably, eyes with treatment success showed better BCVA at all timepoints and gained more letters compared to failures.

Conclusion: Single or repetitive SRT may be an effective and safe treatment in 2 of 3 patients suffering from acute persistent CSC after 6 months of symptoms or more. We observed complete resolution of SRF in around 60% of eyes 12 weeks after first SRT treatment and also 12 weeks after Re-SRT treatment in eyes with persistent or recurrent SRF. Results on the long-term course after SRT are still pending.
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http://dx.doi.org/10.1007/s00417-020-04999-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8166675PMC
June 2021

[Bilateral posterior serous retinal detachment associated with HELLP syndrome].

Ophthalmologe 2021 Nov 4;118(11):1140-1142. Epub 2020 Nov 4.

Universitätsklinik für Augenheilkunde, Medizinische Hochschule Hannover, Carl-Neuberg-Str. 1, 30625, Hannover, Deutschland.

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http://dx.doi.org/10.1007/s00347-020-01257-5DOI Listing
November 2021

Surgical outcomes in patients with optic disc pit maculopathy: does peeling the ILM lead to better outcomes?

Int Ophthalmol 2020 Dec 1;40(12):3363-3376. Epub 2020 Aug 1.

Eye Center at Medical Center, University of Freiburg, Killianstrasse 5, Freiburg, Germany.

Purpose: Optic disc pits (ODPs) are rare congenital anomalies. Several patients develop optic disc pit maculopathy (ODP-M): visual impairment caused by intra- and/or subretinal fluid. Treatment mode remains controversial. This study was designed to investigate the effectiveness of pars plana vitrectomy (PPV) and gas tamponade with or without internal limiting membrane (ILM)-peeling in improving visual acuity and reducing subretinal fluid in ODP-M patients.

Methods: We retrospectively reviewed the charts of 16 patients who underwent surgery for ODP-M from 2002-2015. Six patients underwent PPV with gas tamponade (group 1); ten patients additionally received ILM-peeling (group 2). Pre- and postoperative visual acuity and central retinal thickness (CRT) were compared between groups, as well as retinal morphology and the number of secondary vitrectomies and complications.

Results: Median visual acuity improved by 2 ETDRS lines in both groups (p = 0.713, Mann-Whitney U test). Median CRT decreased by 426.5 µm and 460 µm (p = 0.931). One patient in group 1 underwent repeat vitrectomy for persistent retinoschisis. Three patients in group 2 required repeat vitrectomy: two to treat a macular hole, one for peripheral retinal holes with retinal detachment.

Conclusion: In our cohort, PPV with gas tamponade proved to be an effective first-line treatment for ODP-M. Additional ILM-peeling did not give a significant benefit in this study.
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http://dx.doi.org/10.1007/s10792-020-01524-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8370961PMC
December 2020

Comparison of Macular Pigment Optical Density in Glaucoma Patients and Healthy Subjects - A Prospective Diagnostic Study.

Clin Ophthalmol 2020 1;14:1011-1017. Epub 2020 Apr 1.

University Eye Hospital, Hannover Medical School, Hannover 30625, Germany.

Purpose: To evaluate the relationship between macular pigment optical density (MPOD) and glaucoma.

Methods: Forty-three patients with an established glaucoma diagnosis (25 females, 18 males, mean age 70 (range 34-84)) and 43 healthy controls (28 females, 15 males, mean age 62 (range 30-87)) were included in this prospective diagnostic case-control study. All subjects underwent detailed eye examination including ophthalmoscopy, best-corrected visual acuity, biomicroscopy, measurement of the axial length of the eye, objective refraction, lens status, central foveal thickness on spectral-domain optical coherence tomography (SD-OCT). In all glaucoma patients, a visual field assessment and a measurement of the retinal nerve fibre layer (RNFL) on SD-OCT were done. MPOD was determined using the macula pigment module of the Spectralis HRA+OCT (Heidelberg Engineering GmbH, Heidelberg, Germany) at 0.51°, 1.02° and 1.99° retinal eccentricity using two-wavelength autofluorescence imaging.

Results: In the glaucoma group, the median of the visual field mean defect was 5.1 db (quartiles 3.0 and 13.5) and the mean RNFL-thickness global was 65.9 µm (SD ± 16.1). Median MPOD measured at 0.51°, 1.02° and 1.99° retinal eccentricity in the glaucoma group was 0.42 DU, 0.34 DU and 0.13 DU, in the control group 0.40 DU, 0.35 DU and 0.12 DU respectively. There was no statistically significant difference of median MPOD between glaucomatous and control eyes (p=0.510, 0.735, 0.481). No significant relation between MPOD at 1.02 retinal eccentricity and the presence of glare symptoms was found (p=0.948). However, age seems to correlate with median MPOD measured at 1.02 retinal eccentricity (p=0.017).

Conclusion: There was no evidence for lower MPOD levels in our glaucoma patients; lower MPOD was not related to the presence of glare symptoms. However there seems to be a positive correlation between age and MPOD at 1.02° retinal eccentricity. To further investigate the relation between glare reported by glaucoma patients and glare disability linked to lower MPOD levels, additional studies are necessary that include both detailed inquiry of the quality of glare and a glare quantification and precise analysis of MPOD levels in glaucoma patients.
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http://dx.doi.org/10.2147/OPTH.S224259DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7140904PMC
April 2020

How and why SGLT2 inhibitors should be explored as potential treatment option in diabetic retinopathy: clinical concept and methodology.

Ther Adv Endocrinol Metab 2019 11;10:2042018819891886. Epub 2019 Dec 11.

MHH Clinical Research Center Core Facility (OE 8660) and Center for Pharmacology and Toxicology, Hannover, Germany.

Patients suffering from type 2 diabetes are at an increased risk of developing classical microvascular complications such as retinopathy, neuropathy, and nephropathy, which represent a significant health burden. Tight control of blood glucose, blood pressure, and serum cholesterol reduce the risk of microvascular complications but effective pharmacologically targeted treatment options for the treatment and prevention of diabetic microangiopathy are still lacking. Pharmacological inhibition of sodium glucose cotransporter 2 (SGLT2) might have the potential to directly protect against microvascular complications and could represent a potential treatment option. Randomized controlled clinical proof of concept trials are needed to investigate a potential central role of SGLT2 inhibitors in the prevention of diabetic microangiopathy and its classical clinical complications of retinopathy, neuropathy, and nephropathy.
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http://dx.doi.org/10.1177/2042018819891886DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6906337PMC
December 2019

Ranibizumab Pro Re nata versus Dexamethasone in the Management of Ischemic Retinal Vein Occlusion: Analysis from the COMRADE Trials.

Curr Eye Res 2020 05 31;45(5):604-614. Epub 2019 Oct 31.

Eye Hospital, Universitätsklinikum Leipzig, Leipzig, Germany.

: To compare ischemia-related clinical outcomes in patients treated with either ranibizumab pro re nata (PRN) or single dexamethasone implant in the Branch Retinal Vein Occlusion (COMRADE-B) or Central Retinal Vein Occlusion (COMRADE-C) trials.: A analysis of the Phase IIIb, 6-month, multicenter, double-masked, randomized, COMRADE-B and COMRADE-C trials. Change over 6 months in retinal ischemia status (central avascular [CA] zone and peripheral nonperfusion [PNP]), mean best-corrected visual acuity (BCVA), the development of shunt vessels and neovascularization, and frequency of laser therapy were assessed in retinal vein occlusion (RVO) patients treated with either ranibizumab 0.5 mg PRN or single dexamethasone 0.7 mg implant, as per European labels, in the COMRADE-B (N = 244; ranibizumab, 126, dexamethasone, 118) or COMRADE-C (N = 243; ranibizumab, 124, dexamethasone, 119) trials. BCVA progression in ischemic vs. non-ischemic patients based on the ischemia assessment at month 6 was carried out.: Visual acuity (VA) gains from baseline to month 6 were higher with ranibizumab than with dexamethasone in both patients with central ischemia and those with peripheral retinal nonperfusion, independent of the type of RVO (branch or central). The presence of CA and PNP had a significant impact on VA gain over 6 months in CRVO patients ( < .0001), while there was no significant impact in BRVO. Ranibizumab was associated with less new ischemia than dexamethasone. Central RVO patients treated with dexamethasone received more laser treatments over the 6 months than those treated with ranibizumab, while there was no difference in the frequency of laser therapy between the branch RVO treatment groups.: VA gain over six months in ranibizumab-treated RVO patients is not affected by ischemia, and is associated with less development of new ischemia during the first 6 months of treatment and equal or fewer laser treatments than dexamethasone implant.
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http://dx.doi.org/10.1080/02713683.2019.1679839DOI Listing
May 2020

Selective retina therapy: toward an optically controlled automatic dosing.

J Biomed Opt 2018 11;23(11):1-12

Medizinisches Laserzentrum Lübeck GmbH, Lübeck, Germany.

Selective retina therapy (SRT) targets the retinal pigment epithelium (RPE) with pulsed laser irradiation by inducing microbubble formation (MBF) at the intracellular melanin granula, which leads to selective cell disruption. The following wound healing process rejuvenates the chorio-retinal junction. Pulse energy thresholds for selective RPE effects vary intra- and interindividually. We present the evaluation of an algorithm that processes backscattered treatment light to detect MBF as an indicator of RPE cell damage since these RPE lesions are invisible during treatment. Eleven patients with central serous chorioretinopathy and four with diabetic macula edema were treated with a SRT system, which uses a wavelength of 527 nm, a repetition rate of 100 Hz, and a pulse duration of 1.7 μs. Fifteen laser pulses with stepwise increasing pulse energy were applied per treatment spot. Overall, 4626 pulses were used for algorithm parameter optimization and testing. Sensitivity and specificity were the metrics maximized through an automatic optimization process. Data were verified by fluorescein angiography. A sensitivity of 1 and a specificity of 0.93 were achieved. The method introduced in this paper can be used for guidance or automatization of microbubble-related treatments like SRT or selective laser trabeculoplasty.
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http://dx.doi.org/10.1117/1.JBO.23.11.115002DOI Listing
November 2018

Optical coherence tomography angiography analysis of macular flow density in glaucoma.

Acta Ophthalmol 2019 Mar 4;97(2):e199-e206. Epub 2018 Sep 4.

Hannover Medical School, University Eye Hospital, Hannover, Germany.

Purpose: Modifications in ocular blood flow may play a significant role in glaucoma development. Optical coherence tomography angiography (OCT-A) is based on the detection and analysis of the reflection behaviour of motion in a static environment and therefore is able to quantify the retinal flow density. We used this new technology to examine the density of the active flow vasculature in the macular area in glaucoma patients compared to healthy patients.

Methods: Thirty patients with primary open-angle glaucoma (mean age: 72.6 ± 7.1 years) and 21 healthy patients (mean age: 70.3 ± 8.6 years) were recruited. Patients received perimetry and OCT measurements of the peripapillary retinal nerve fibre layer thickness (RNFLT) and macular retinal thickness and OCT-A of the macular area in the superficial and deep retinal (DR) plexus. Flow density of the OCT-A scan was calculated by binarisation and quantification of the pixel density.

Results: Macular flow density was globally and nasally reduced in glaucoma patients in the superficial (globally: p = 0.0203; nasally: p = 0.0003) and DR plexus (globally: p = 0.0113, nasally: p < 0.0001). There was no significant difference between the superficial retina and the DR concerning the flow density. Flow density showed no significant correlation with perimetry results, RNFLT or retinal segment thickness.

Conclusion: Patients with glaucoma exhibit a reduced macular flow density measured by OCT-A compared to controls. The independence of the macular flow density of the retinal segment thickness changes could indicate an altered vascular element in patients with glaucoma.
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http://dx.doi.org/10.1111/aos.13914DOI Listing
March 2019

Comparison of ranibizumab versus dexamethasone for macular oedema following retinal vein occlusion: 1-year results of the COMRADE extension study.

Acta Ophthalmol 2018 Dec 31;96(8):e933-e941. Epub 2018 May 31.

Georg-August-University Goettingen, University Eye Hospital, Goettingen, Germany.

Purpose: The COMRADE studies are the first randomized controlled head-to-head trials comparing the efficacy and safety of intravitreal ranibizumab versus dexamethasone (DEX) in patients with macular oedema secondary to retinal vein occlusion (RVO). The COMRADE extension trial was designed to provide additional 6-month data of patients who completed the core studies.

Methods: In this open-label, phase IV study patients who completed the COMRADE core studies were prospectively enrolled. Overall, 92 branch RVO (BRVO) patients (ranibizumab 52, DEX 40) and 83 central RVO (CRVO) patients (ranibizumab 61, DEX 22) were treated, and 94.6% of BRVO patients and 97.6% of CRVO patients completed the extension study. Patients were assigned to the same treatment group as in the core studies. Patients were monitored monthly and received either 0.5 mg ranibizumab or a 0.7 mg DEX implant as needed.

Results: Over the course of the extension, treatment-emergent adverse events (TEAEs) of the study eye occurred in 55.8% of BRVO patients on ranibizumab and in 62.5% of those on DEX. Among CRVO patients, 65.5% in the ranibizumab group and 59.1% in the DEX group developed TEAEs. Overall, elevated intraocular pressure (IOP) was more frequent with DEX than ranibizumab treatment. Mean average change in best-corrected visual acuity (BCVA) in BRVO patients was significantly better for ranibizumab than DEX (p = 0.0249). The CRVO results were consistent with BRVO's, although not significant (p = 0.1119).

Conclusion: When used according to the European labels, ranibizumab revealed a better ocular safety profile and produced greater average BCVA gains than DEX. By the end of the additional 6-month study period, this difference in BCVA was more pronounced in BRVO as in CRVO patients. The main limitation of the COMRADE studies was that DEX patients received only a single intravitreal treatment during the first 6 months, which is presumably not adequate. However, frequent DEX implants could lead to more steroid-related side effects, especially to an increased intraocular pressure.
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http://dx.doi.org/10.1111/aos.13770DOI Listing
December 2018

Intraoperative optical coherence tomography and ab interno trabecular meshwork surgery with the Trabectome.

Clin Ophthalmol 2017 28;11:1755-1760. Epub 2017 Sep 28.

University Eye Hospital, Medical School Hannover, Hannover.

Importance: This study is the first description of the use of the intraoperative optical coherence tomography (iOCT) for trabecular meshwork surgery with the Trabectome in a regular clinical setting.

Background: The aim of this study is to evaluate intraoperatively the immediate success of ab interno trabeculotomy with the Trabectome defined as a removal of the trabecular meshwork.

Design: This is a retrospective clinical study performed in the University Eye Hospital, Medical School Hannover.

Participants: A total of nine consecutive Caucasian patients suffering from primary open angle glaucoma, pigment dispersion glaucoma, or pseudoexfoliation glaucoma took part in the study.

Methods: All patients underwent ab interno trabeculotomy surgery with the Trabectome using a commercially available iOCT to visualize the anterior chamber angle (ACA) before and after the procedure. The visualization was done using a modified Swan-Jacobs lens (all nine patients) or without lens (view from above, five patients).

Main Outcome Measures: The main outcome of this study is the success of visualization of the ACA on iOCT, especially the postprocedural visualization of the wound gap after removal of the trabecular meshwork.

Results: Using the view from above, the ACA could be visualized before and after the procedure in only two of the five cases. Using the modified Swan-Jacobs lens, the ACA could be visualized before the procedure and the trabecular meshwork opening after the procedure in all nine patients.

Conclusion: The iOCT can be used to objectify the immediate success of the surgical procedure, ie, the removal of the trabecular meshwork, of ab interno trabeculotomy with the Trabectome. The procedure itself cannot be captured sufficiently via iOCT.
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http://dx.doi.org/10.2147/OPTH.S145873DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5627725PMC
September 2017

Integrated results from the COPERNICUS and GALILEO studies.

Clin Ophthalmol 2017 23;11:1533-1540. Epub 2017 Aug 23.

Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA.

Objectives: To report on the efficacy and safety of intravitreal aflibercept in patients with macular edema secondary to central retinal vein occlusion (CRVO) in an integrated analysis of COPERNICUS and GALILEO.

Patients And Methods: Patients were randomized to receive intravitreal aflibercept 2 mg every 4 weeks or sham injections until week 24. From week 24 to week 52, all intravitreal aflibercept-treated patients in both studies and sham-treated patients in COPERNICUS were eligible to receive intravitreal aflibercept based on prespecified criteria. In GALILEO, sham-treated patients continued to receive sham treatment through week 52.

Results: At week 24, mean gain in best-corrected visual acuity and mean reduction in central retinal thickness were greater for intravitreal aflibercept-treated patients compared with sham, consistent with individual trial results. At week 52, after 6 months of intravitreal aflibercept as-needed treatment in COPERNICUS, patients originally randomized to sham group experienced visual and anatomic improvements but did not improve to the extent of those initially treated with intravitreal aflibercept, while the sham group in GALILEO did not improve over week 24 mean best-corrected visual acuity scores. Ocular serious adverse events occurred in <10% of patients.

Conclusion: This analysis of integrated data from COPERNICUS and GALILEO confirmed that intravitreal aflibercept is an effective treatment for macular edema following CRVO.
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http://dx.doi.org/10.2147/OPTH.S140665DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5574701PMC
August 2017

Switch of Intravitreal Therapy for Macular Edema Secondary to Retinal Vein Occlusion from Anti-VEGF to Dexamethasone Implant and Vice Versa.

J Ophthalmol 2017 30;2017:5831682. Epub 2017 Jul 30.

University Eye Hospital, Hanover Medical School, Hanover, Germany.

Purpose: To evaluate the anatomical and functional outcome of intravitreal dexamethasone implant for macular edema secondary to central (C) or branch (B) retinal vein occlusion (RVO) in patients with persistent macular edema (ME) refractory to intravitreal antivascular endothelial growth factor (VEGF) treatment compared to treatment naïve patients and to dexamethasone-refractory eyes switched to anti-VEGF.

Methods: Retrospective, observational study including 30 eyes previously treated with anti-VEGF (8 CRVO, 22 BRVO, mean age 69 ± 10 yrs), compared to 11 treatment naïve eyes (6 CRVO, 5 BRVO, 73 ± 11 yrs) and compared to dexamethasone nonresponders (2 CRVO, 4 BRVO, 69 ± 12). Outcome parameters were change in best-corrected visual acuity (BCVA) and central foveal thickness (CFT) measured by spectral-domain optical coherence tomography.

Results: Mean BCVA improvement after switch to dexamethasone implant was 4 letters ( = 0.08), and treatment naïve eyes gained 10 letters ( = 0.66), while we noted no change in eyes after switch to anti-VEGF ( = 0.74). Median CFT decrease was most pronounced in treatment naïve patients (-437 m, = 0.002) compared to anti-VEGF refractory eyes (-170 m, = 0.003) and dexamethasone-refractory eyes (-157, = 0.31).

Conclusions: Dexamethasone significantly reduced ME secondary to RVO refractory to anti-VEGF. Functional gain was limited compared to treatment naïve eyes, probably due to worse BCVA and CFT at baseline in treatment naïve eyes.
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http://dx.doi.org/10.1155/2017/5831682DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5554567PMC
July 2017

Author's reply to comments to: Visual and anatomic outcomes after conversion to aflibercept in neovascular age-related macular degeneration: 12-month results.

Eur J Ophthalmol 2017 06 26;27(4):e135. Epub 2017 Jun 26.

University Eye Hospital, Hannover Medical School, Hannover - Germany.

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http://dx.doi.org/10.5301/ejo.5000981DOI Listing
June 2017

Head-to-head comparison of ranibizumab PRN versus single-dose dexamethasone for branch retinal vein occlusion (COMRADE-B).

Acta Ophthalmol 2018 Feb 2;96(1):e10-e18. Epub 2017 Mar 2.

Department of Ophthalmology, Georg-August-University Göttingen, Göttingen, Germany.

Purpose: To compare the efficacy and safety of ranibizumab 0.5 mg versus dexamethasone 0.7 mg according to their European labels in macular oedema secondary to branch retinal vein occlusion (BRVO) in a 6-month, phase IIIb, randomized trial.

Methods: Patients received either monthly ranibizumab for 3 months followed by Pro re nata (PRN) treatment (n = 126) or a sustained-release dexamethasone implant followed by PRN sham injections (n = 118). Main outcomes were mean average change in best-corrected visual acuity (BCVA) from baseline to month 1 through month 6, mean changes in BCVA and foveal centre point thickness (FCPT), and adverse events (AEs).

Results: There was no difference in BCVA gains between the treatments prior to month 3. Best-corrected visual acuity (BCVA) gain with dexamethasone declined thereafter. From month 3 to month 6, mean BCVA change from baseline was significantly higher with ranibizumab than with dexamethasone [raw means (standard deviation):+16.2 (±11) letters versus +9.3 (±10.1) letters]. At month 6, the difference in BCVA gains from baseline was +17.3 letters in the ranibizumab versus +9.2 letters in the dexamethasone group. Patients in the ranibizumab group received a mean of 2.94 loading injections and 1.74 PRN retreatment injections, while those in the dexamethasone group received a single loading injection. Elevated intraocular pressure (IOP) and AEs were more frequent with dexamethasone than ranibizumab treatment.

Conclusion: Ranibizumab PRN resulted in greater visual acuity (VA) gains in macular oedema following BRVO compared with single-dose dexamethasone over a 6-month study period, observed from month 3, when administered according to their European label. In clinical practice, retreatment with dexamethasone may be required prior to this point.
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http://dx.doi.org/10.1111/aos.13381DOI Listing
February 2018

Fingolimod Associated Bilateral Cystoid Macular Edema-Wait and See?

Int J Mol Sci 2016 Dec 14;17(12). Epub 2016 Dec 14.

Department of Neurology, Hannover Medical School, 30625 Hannover, Germany.

Fingolimod 0.5-mg once-daily is an approved therapy for patients with relapsing-remitting multiple sclerosis (MS). Several pivotal and real-world studies have demonstrated that fingolimod is associated with the development of macular edema (ME). Herein, we present a case of a diabetic MS patient who developed severe bilateral ME during fingolimod treatment. By means of this case study we provide a detailed review about fingolimod associated macular edema (FAME), its current incidence with or without diabetes mellitus, and previous therapy attempts and outcomes in MS patients. Intravitreal administration of antibodies raised against vascular endothelial growth factor A (VEGF-A) has not yet been used in the management of FAME, however, the excellent therapeutic response in our patient may justify the use of anti-VEGF-A agents in combination with cessation of fingolimod to achieve fast resolution of FAME and to prevent visual deficits, particularly in bilateral FAME.
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http://dx.doi.org/10.3390/ijms17122106DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5187906PMC
December 2016

Predictive factors for functional improvement following intravitreal bevacizumab injections after central retinal vein occlusion.

Graefes Arch Clin Exp Ophthalmol 2017 Mar 8;255(3):457-462. Epub 2016 Sep 8.

Eye Clinic Sulzbach, Knappschaftsklinikum Sulzbach Saar, An der Klinik 10, 66111, Sulzbach/Saar, Germany.

Purpose: Vision loss in central retinal vein occlusion (CRVO) is mostly caused by macular edema (ME) and can be treated with intravitreal bevacizumab injections. The goal of this study was to identify predictive factors for improvement in visual acuity.

Methods: Three hundred and sixteen eyes of six centres having received intravitreal bevacizumab for ME due to CRVO were enrolled in this multicentre, retrospective, interventional case series. The follow-up time was 24 to 48 weeks. Investigated patient characteristics were pretreatment, duration of CRVO prior to the first injection, initial best-corrected visual acuity (BCVA), baseline central retinal thickness as measured by optical coherence tomography, gender, eye, age, comorbidity with glaucoma, systemic hypertension, or diabetes mellitus.

Results: Multiple regression analysis confirmed the following baseline predictive factors for an increase in visual acuity: low BCVA (p < 0.001), high CRT (p < 0.02), and treatment naïve patients (p = 0.03). None of the other investigated patient characteristics could be identified as prognostic factors for increase in visual acuity (p > 0.1).

Conclusions: Intravitreal injections of bevacizumab in a routine clinical setting effectively improved and stabilized BCVA in CRVO. Our large multicenter study identified initial BCVA, baseline CRT, and pre-treatment as prognostic factors for visual improvement.
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http://dx.doi.org/10.1007/s00417-016-3471-2DOI Listing
March 2017

Vitrectomy with and without encircling band for pseudophakic retinal detachment: VIPER Study Report No 2-main results.

Br J Ophthalmol 2017 06 8;101(6):712-718. Epub 2016 Sep 8.

Department of Ophthalmology, RWTH Aachen University, Aachen, Germany.

Background: It is unclear whether or not an additional encircling band improves outcome in vitrectomy for pseudophakic retinal detachment (PRD). Also unclear is whether small gauge transconjunctival trocar-guided vitrectomy is as successful as conventional 20 gauge (G) vitrectomy.

Methods: 257 adult patients with uncomplicated PRD were enrolled in 14 vitreoretinal centres across Germany. Contingent on availability of qualified surgeons, eligible patients were randomly assigned either (i) with ratio 1:1 to 20 G vitrectomy plus encircling band (group E1) or 20 G vitrectomy without any buckle (group C) or (ii) with ratios 1:1:1 to group E1, C or 23/25 G vitrectomy without any buckle (group E2). Treatment success was defined as no indication for any retina reattaching procedure during the follow-up of 6 months.

Results: Success was reached in 79.0% (=79/100, group E1) versus 73.5% (=72/98, group C) (p=0.558, OR 1.32, 95% CI 0.65 to 2.65. In group E2 87.7% (=50/57) of patients reached success compared with 78.7% (=48/61) in group C, demonstrating non-inferiority of E2 to C regarding the prespecified margin of 0.8 (OR scale; p=0.05, OR 2.17, 95% CI 0.80 to 5.89). Best corrected visual acuity significantly increased after surgery independent of technique, that is, on average -0.7 (from 1.0 to 0.3) logMAR. Patients suffered from a shift in spherical refraction of -1.0 D in group E1 compared with -0.1 D in group C. Similarly, intraoperative complications (15.2% vs 8.8% of patients) and serious adverse events (30.3% vs 22.5% of patients) were more frequent in group E1.

Conclusions: Vitrectomy with gas is an efficient and safe treatment for uncomplicated PRD. An additional encircling band does not significantly reduce the risk for any second procedure necessary to reattach the retina in 20 G vitrectomy. Small gauge transconjunctival vitrectomy is not inferior to the conventional 20 G technique.

Trial Registration Number: DKRS 00003158, Results.
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http://dx.doi.org/10.1136/bjophthalmol-2016-309240DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5583681PMC
June 2017

The German ROP Registry: data from 90 infants treated for retinopathy of prematurity.

Acta Ophthalmol 2016 Dec 20;94(8):e744-e752. Epub 2016 May 20.

Eye Center, University of Freiburg, Freiburg, Germany.

Purpose: The German retinopathy of prematurity (ROP) Registry collects data on treated ROP in a multicentre approach to analyse epidemiology and treatment patterns of severe ROP.

Methods: Nine centres entered data from 90 treated ROP infants (born between January 2011 and December 2013) into a central database. Analysis included incidence rate of severe ROP, demographic data, stage of ROP, treatment patterns, recurrence rates, relevant comorbidities and ophthalmological or systemic complications associated with treatment.

Results: Treatment rate for ROP was 3.2% of the screened population. The most frequent ROP stage at time of treatment was zone II, stage 3 +  (137 eyes). Treatment was bilateral in 97% of infants. Treatment patterns changed over time from 7% anti-vascular endothelial growth factor (VEGF) monotherapy in 2011 to 32% in 2014. Overall, laser treatment was the predominant treatment. However, all infants with zone I disease received anti-VEGF treatment. About 19% of infants required retreatment (16% of laser-treated and 21% of anti-VEGF treated infants). Mean time between first and second treatment was 3.8 weeks (± 11 days) for laser-treated and 10.4 weeks (± 60 days) for anti-VEGF-treated infants.

Conclusion: This study is the first multicentre analysis of severe ROP in Germany. The identified treatment patterns find laser as the most prevalent form of therapy, with an increasing use of anti-VEGF therapy over recent years. Recurrence rates were relatively high overall with slightly higher recurrence rates and later recurrence times in the anti-VEGF group. Anti-VEGF was predominantly used for high-risk stages like AP-ROP and zone I disease.
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http://dx.doi.org/10.1111/aos.13069DOI Listing
December 2016

Clinical Efficacy and Safety of Ranibizumab Versus Dexamethasone for Central Retinal Vein Occlusion (COMRADE C): A European Label Study.

Am J Ophthalmol 2016 Sep 7;169:258-267. Epub 2016 May 7.

Department of Ophthalmology, Ludwigshafen Hospital, Ludwigshafen, Germany.

Purpose: To compare the efficacy and safety of the European labels of ranibizumab 0.5 mg vs dexamethasone 0.7 mg in patients with macular edema secondary to central retinal vein occlusion (CRVO).

Design: Phase IIIb, multicenter, double-masked, randomized clinical trial.

Methods: Patients were randomized (1:1) to receive either monthly ranibizumab followed by pro re nata (PRN) treatment (n = 124) or 1 sustained-release dexamethasone implant followed by PRN sham injections (n = 119). Main outcomes were mean average change in best-corrected visual acuity (BCVA) from baseline to month 1 through month 6, mean change in BCVA, and adverse events (AEs).

Results: Of 243 patients, 185 (76.1%) completed the study. No difference was observed in BCVA between ranibizumab and dexamethasone at months 1 and 2. From month 3 to month 6, there was significant difference in BCVA gains in favor of ranibizumab. At month 6, mean average BCVA gain was significantly higher with ranibizumab than with dexamethasone (12.86 vs 2.96 letters; difference 9.91 letters, 95% confidence interval [6.51-13.30]; P < .0001). Mean injection number of ranibizumab was 4.52. Ocular AEs were reported in more patients in the dexamethasone than in the ranibizumab group (86.6% vs 55.6%).

Conclusions: Using the European labels, similar efficacy was observed for ranibizumab and dexamethasone at months 1 and 2. However, ranibizumab maintained its efficacy throughout the study, whereas dexamethasone declined from month 3 onward. The main limitation of the study was that dexamethasone patients received only a single treatment during the 6-month study. In clinical practice, dexamethasone retreatment may be required earlier than 6 months. Safety findings were similar to those previously reported.
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http://dx.doi.org/10.1016/j.ajo.2016.04.020DOI Listing
September 2016

The short-term effects of aflibercept on the size of choroidal neovascularization lesion in treatment-resistant neovascular age-related macular degeneration as determined by spectral-domain optical coherence tomography.

Lasers Surg Med 2016 09 25;48(7):668-77. Epub 2016 Apr 25.

Department of Ophthalmology, University Eye Hospital, Hannover Medical School, Hannover, Germany.

Background And Objectives: To evaluate the changes in the size of choroidal neovascularization (CNV) lesion using spectral domain-optical coherence tomography (SD-OCT) in patients with treatment-resistant neovascular age-related macular degeneration (AMD) who were switched from ranibizumab to aflibercept.

Materials And Methods: In this prospective case-series, 33 eyes of 30 patients with treatment-resistant neovascular AMD were included. Treatment-resistant neovascular AMD was defined as choriodal neovascularization secondary to AMD determined by subretinal fluid and/or intraretinal fluid/cysts after more than 6 months of monthly ranibizumab therapy. Enrolled eyes were received intravitreal aflibercept injections at weeks 0, 4, and 8. Maximum area of CNV lesion in the cross-sectional area in the B-scan was measured using Heidelberg Eye Explorer software. The same cross-sectional sections containing maximum area of CNV lesion were used during the follow-up. CNV subtypes were determined based on fluorescein angiography images prior to ranibizumab therapy. Main outcome measures were changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), and area of CNV lesion.

Results: There were five classic (15%), seven minimally classic (21%), and 21 occult subtypes of CNV (64%). Four weeks after the third injection, BCVA improvement and reduction of the retinal thickness in nine standard ETDRS subfields were significant (both P < 0.001). Regarding and regardless of CNV subtypes, mean area of CNV lesion decreased significantly at final visit. Overall, a dry macula was achieved in 21 eyes (64%) and 12 eyes (36%) showed decreased or unchanged edema.

Conclusions: Switching to aflibercept seems to result in reduction of CNV lesion area in short-term follow-up of patients with treatment-resistant neovascular AMD. Lasers Surg. Med. 48:668-677, 2016. © 2016 Wiley Periodicals, Inc.
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http://dx.doi.org/10.1002/lsm.22531DOI Listing
September 2016

Treatment of optic neuritis with erythropoietin (TONE): a randomised, double-blind, placebo-controlled trial-study protocol.

BMJ Open 2016 Mar 1;6(3):e010956. Epub 2016 Mar 1.

Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany.

Introduction: Optic neuritis leads to degeneration of retinal ganglion cells whose axons form the optic nerve. The standard treatment is a methylprednisolone pulse therapy. This treatment slightly shortens the time of recovery but does not prevent neurodegeneration and persistent visual impairment. In a phase II trial performed in preparation of this study, we have shown that erythropoietin protects global retinal nerve fibre layer thickness (RNFLT-G) in acute optic neuritis; however, the preparatory trial was not powered to show effects on visual function.

Methods And Analysis: Treatment of Optic Neuritis with Erythropoietin (TONE) is a national, randomised, double-blind, placebo-controlled, multicentre trial with two parallel arms. The primary objective is to determine the efficacy of erythropoietin compared to placebo given add-on to methylprednisolone as assessed by measurements of RNFLT-G and low-contrast visual acuity in the affected eye 6 months after randomisation. Inclusion criteria are a first episode of optic neuritis with decreased visual acuity to ≤ 0.5 (decimal system) and an onset of symptoms within 10 days prior to inclusion. The most important exclusion criteria are history of optic neuritis or multiple sclerosis or any ocular disease (affected or non-affected eye), significant hyperopia, myopia or astigmatism, elevated blood pressure, thrombotic events or malignancy. After randomisation, patients either receive 33,000 international units human recombinant erythropoietin intravenously for 3 consecutive days or placebo (0.9% saline) administered intravenously. With an estimated power of 80%, the calculated sample size is 100 patients. The trial started in September 2014 with a planned recruitment period of 30 months.

Ethics And Dissemination: TONE has been approved by the Central Ethics Commission in Freiburg (194/14) and the German Federal Institute for Drugs and Medical Devices (61-3910-4039831). It complies with the Declaration of Helsinki, local laws and ICH-GCP.

Trial Registration Number: NCT01962571.
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http://dx.doi.org/10.1136/bmjopen-2015-010956DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4785322PMC
March 2016

Visual and anatomic outcomes after conversion to aflibercept in neovascular age-related macular degeneration: 12-month results.

Eur J Ophthalmol 2016 Aug 5;26(5):473-8. Epub 2016 Feb 5.

Department of Ophthalmology, University Eye Hospital, Hannover Medical School, Hannover - Germany.

Purpose: To investigate 12-month outcomes of conversion to aflibercept in patients with neovascular age-related macular degeneration resistant to ranibizumab.

Methods: Twenty-two eyes of 19 consecutive patients received 3 monthly aflibercept injections followed by a pro re nata protocol. Spectral-domain optical coherence tomography (OCT) images were obtained before each injection. All 49 cross-sectional OCT B-scans obtained in each examination were investigated and the largest choroidal neovascularization (CNV) size was chosen. The same cross-sectional B-scan sections containing the maximum CNV size were used during the follow-up.

Results: After 12 months, best-corrected visual acuity increased from 45.68 ± 20.25 to 59.09 ± 17.50 Early Treatment Diabetic Retinopathy Study letters (p<0.001), central subfield thickness decreased from 399.91 ± 148.85 to 304.55 ± 97.89 μm (p = 0.003), area of CNV declined from 0.38 ± 0.24 to 0.28 ± 0.19 mm2 (p = 0.003), and macular volume improved from 9.64 ± 1.75 to 8.45 ± 0.98 mm3 (p<0.001). There was a significant resolution of intraretinal fluid (p = 0.016), but reduction of subretinal fluid was not significant (p = 0.25).

Conclusions: Visual and anatomic improvement were obtained after conversion to aflibercept.
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http://dx.doi.org/10.5301/ejo.5000757DOI Listing
August 2016

Correlation Between Hyperreflective Foci and Clinical Outcomes in Neovascular Age-Related Macular Degeneration After Switching to Aflibercept.

Invest Ophthalmol Vis Sci 2015 Oct;56(11):6448-55

University Eye Hospital Hannover Medical School, Hannover, Germany.

Purpose: To assess the correlation between hyperreflective foci (HF) and visual and anatomical outcomes in treatment-resistant neovascular age-related macular degeneration (AMD) using spectral-domain optical coherence tomography (SD-OCT).

Methods: This was a prospective interventional case series. Thirty-three eyes of 30 consecutive patients with treatment-resistant neovascular AMD were enrolled. Intravitreal aflibercept injections were performed at week 0 (baseline), week 4, and week 8. Spectral-domain OCT images were obtained before each injection and 4 weeks after the third injection. The main focus was on the measurement of choroidal neovascularization (CNV) size in the cross-sectional area in the B-scan through the fovea, and HF number along line segments of 1- and 3-mm length passing through the fovea.

Results: Mean number of HF in the radius of 500 μm decreased from 8.36 ± 7.58 to 4.15 ± 3.39 (P = 0.02). Mean number of HF in the radius of 1500 μm was reduced from 21.30 ± 12.47 to 10.45 ± 6.34 (P < 0.001). Mean CNV area decreased from 0.35 ± 0.22 to 0.22 ± 0.16 mm2 (P < 0.001). There was a significant positive correlation between HF reduction in the radius of 500 μm and decrease in central subfield thickness (CST) (r = 0.43, P = 0.01), but no statistically significant correlation was found between HF decline in the radius of 1500 μm and other parameters.

Conclusions: Switching from ranibizumab to aflibercept caused significant decrease in the number of HF 1 month after aflibercept upload, and HF decrease in the radius of 500 μm was correlated positively with the reduction in CST.
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http://dx.doi.org/10.1167/iovs.15-17338DOI Listing
October 2015
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