Publications by authors named "Jay U Sheth"

16 Publications

  • Page 1 of 1

Brolucizumab in Neovascular Age-Related Macular Degeneration - Indian Real-World Experience: The BRAILLE Study.

Clin Ophthalmol 2021 7;15:3787-3795. Epub 2021 Sep 7.

Department of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, West Bengal, India.

Purpose: To assess the short-term efficacy and safety profile of intravitreal brolucizumab injection in Indian eyes with neovascular age-related macular degeneration (nAMD) under real-world conditions.

Patients And Methods: This was a multicenter, retrospective chart review of 94 eyes of 94 patients with nAMD (treatment-naïve and switch-therapy) undergoing brolucizumab therapy. Re-treatment as per pro-re-nata protocol was performed based on fixed visual and tomographic criteria. The main outcome measures were changes in the best-corrected visual acuity (BCVA), intraretinal fluid (IRF), subretinal fluid (SRF), central subfield thickness (CST), and pigment epithelial detachment (PED) along with safety analysis.

Results: Of the 94 eyes, 20 eyes (21.3%) were treatment-naïve, whereas the rest 74 eyes (78.7%) underwent switch therapy. One hundred and twenty-six injections were given over a mean follow-up of 7.3 ± 2.2 (range 5-30) weeks. The BCVA improved significantly from 0.82 ± 0.5 LogMAR at baseline to 0.66 ± 0.5 LogMAR at the final visit (p < 0.0001). Significant reduction in CST was simultaneously noted (Baseline: 408.45 ± 65.63 µm; Final: 281.14 ± 37.74 µm; p < 0.0001). On qualitative analysis, resolution of subretinal fluid (SRF), intraretinal fluid (IRF), and pigment epithelial detachment (PED) was observed in 15.5%, 39.29%, and 23.81% of the eyes, respectively. The mean interval of repeat injection was 10.2 ± 2.1 weeks. Three episodes of ocular adverse drug reaction were reported, including two patients developing subretinal hemorrhage while one having a retinal pigment epithelial (RPE) tear. Notably, no intraocular inflammation (IOI) was seen in any of the eyes, and no systemic side effects were identified.

Conclusion: In a real-world scenario, brolucizumab therapy is efficacious and safe in the management of nAMD over the short term. Further long-term studies are warranted to validate these findings. Additionally, lack of ocular inflammation after 126 brolucizumab injections in our Indian data is peculiar and underlines the necessity to explore the role of race and genetics in predisposing to/safeguarding against brolucizumab-related IOIs.
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http://dx.doi.org/10.2147/OPTH.S328160DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8434835PMC
September 2021

Off-label intravitreal brolucizumab for recalcitrant diabetic macular edema: A real-world case series.

Am J Ophthalmol Case Rep 2021 Dec 1;24:101197. Epub 2021 Sep 1.

Department of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, India.

Purpose: To report the efficacy of intravitreal injection (IVI) of brolucizumab for recalcitrant diabetic macular edema (DME) in a real-world setting.

Observations: This was a single-center, prospective uncontrolled non-randomized case series. Three eyes with recalcitrant DME, who have received a minimum of ten intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections, underwent IVI brolucizumab and were followed-up for minimum of 16 weeks. Patients underwent best-corrected visual acuity (BCVA) testing, ophthalmic examination, and optical coherence tomography at baseline and all the scheduled follow-up visits (Weeks 4, 8, 12, and 16). All three patients demonstrated notable improvement in BCVA and reduction in the fluid on SD-OCT lasting up to week 12. At week 16, all three eyes maintained the visual acuity gains. However, early increase in fluid was noted in all the three cases, for which second dose of IVI brolucizumab was planned. No ocular or systemic adverse events were noted in any of the cases.

Conclusions And Importance: In this real-world case series, treatment with IVI brolucizumab exhibited excellent visual acuity outcomes lasting up to 16 weeks for the treatment of recalcitrant DME. Single dose IVI brolucizumab achieves good anatomical improvement based on SD-OCT persisting up to 12 weeks, followed by early recurrence of fluid at week 16. The results did not show any ocular or systemic safety concerns for IVI brolucizumab.
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http://dx.doi.org/10.1016/j.ajoc.2021.101197DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8414050PMC
December 2021

De-novo multilayering in fibrovascular pigment epithelial detachment.

Sci Rep 2021 08 26;11(1):17209. Epub 2021 Aug 26.

Vitreoretinal Services, Chaithanya Eye Hospital and Research Institute, Trivandrum, India.

This study describes the occurrence of multilayered pigment-epithelial detachment (MLPED) as a De-novo phenomenon (DN-MLPED) and compare the features with multi-layering secondary to chronic anti-vascular endothelial growth factor (anti-VEGF) therapy (s-MLPED). We did a retrospective evaluation of spectral-domain optical coherence tomography (SD-OCT) features, treatment-profile, and visual-acuity (VA) outcomes in eyes with MLPED. Out of 17 eyes with MLPED, 7 eyes had DN-MLPED and 10 eyes had s-MLPED. There was no significant difference in baseline and final VA between the groups. At the final visit, no significant visual improvement was noted in both the groups, although a possible trend towards an improvement was seen in DN-MLPED eyes while the s-MLPED demonstrated a declining trend (DN-MLPED-LogMAR-BCVA: Baseline = 0.79 [∼ 20/123] ± 0.91; Final = 0.76 [∼ 20/115] ± 0.73; p = 0.87; s-MLPED-LogMAR BCVA: Baseline = 0.43 [∼ 20/54] ± 0.68; Final = 0.94 [∼ 20/174] ± 0.71; p = 0.06). Moreover, after presentation, the median number of injections in DN-MLPED eyes were significantly lower compared to s-MLPED eyes (DN-MLPED:4; s-MLPED:12; p = 0.03) (Median follow-up: DN-MLPED = 26 months; s-MLPED = 54 months; p = 0.15). Subretinal hyperreflective-material (SHRM) deposition heralded the onset of multilayering and was seen to progress in all DN-PED eyes and 1/4 eyes of s-MLPED. To conclude, MLPED is a unique form of cicatrizing fibrovascular-PED which can evolve denovo too. Long-standing disease with intermittent or low-grade activity can potentially explain this unique phenomenon. With fewer anti-VEGF therapy, the de-novo MLPED eyes show more visual stability as compared to s-MLPED eyes.
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http://dx.doi.org/10.1038/s41598-021-96746-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8390466PMC
August 2021

Intraretinal Cysts in Macular Hole: A Structure-Function Correlation Based on En Face Imaging.

Clin Ophthalmol 2021 12;15:2953-2962. Epub 2021 Jul 12.

Vitreoretinal Services, Chaithanya Eye Hospital and Research Institute, Trivandrum, Kerala, India.

Purpose: To characterize retinal micromorphic changes on en face optical coherence tomography (OCT) and to determine their role in pathogenesis and visual outcomes in macular hole (MH) surgery.

Patients And Methods: This is a retrospective, interventional, consecutive case series of 28 eyes undergoing successful MH surgery. Pre- and post-operative en face OCT were manually segmented, and the correlation between parameters such as MH basal diameter and minimal inlet area, area of cyst in inner plexiform layer (IPL) and outer plexiform layer (OPL), percentage of cyst in IPL and OPL, and amount of ellipsoid zone (EZ) defect and external limiting membrane (ELM) defect was performed. Their relationship with visual acuity (VA) outcomes (Group 1: ≥20/60; 14 eyes; Group 2: <20/60; 14 eyes) was also evaluated.

Results: A significant positive correlation was noted between the cyst area in OPL and IPL (r=0.768; p<0.001), which in turn were positively correlated with the basal diameter of the MH in all eyes. The cyst area was significantly more in IPL as compared to OPL in all eyes (p=0.049) and in group 2 (p=0.03) but not in group 1 (p=0.62). As compared to group 2, eyes in group 1 had significantly better pre- and post-operative VA, and significantly smaller basal diameter, minimal inlet area, area of cyst in IPL and OPL, and amount of defect in the ELM (postoperative) and EZ (pre- and post-operative), respectively.

Conclusion: An increase in the basal diameter of the MH is associated with a simultaneous congruous enlargement of the area of cyst in IPL and OPL. Based on these imaging findings, we propose that the possible rationale for the origin of these intraretinal cysts could be a breakdown in the physiological retinal pigment epithelium (RPE) pump due to the anatomical separation of the neurosensory retina from the underlying RPE, ie, "RPE contact loss" theory.
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http://dx.doi.org/10.2147/OPTH.S321594DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8285276PMC
July 2021

Vitreoretinal Society of India practice pattern survey 2020: Surgical retina.

Indian J Ophthalmol 2021 06;69(6):1442-1449

Vitreoretinal Society of India, Chennai, Tamil Nadu; Suven Clinical Research Center, LV Prasad Eye Institute, Hyderabad, Telangana, India.

Purpose: To present the outcomes of the Vitreo-retinal Society of India (VRSI) Practice Pattern Survey 2020 in surgical retina.

Methods: An online survey of members of VRSI was conducted in April 2020 regarding their practice patterns on varied medical and surgical retina topics concerning imaging and management approach. The results were evaluated by two independent experts in this field and compared with the evidence and other practice patterns in the world.

Results: A total of 107 VRSI members participated in the online survey. Responses were obtained on management of wide-ranging surgical retina topics such as diabetic retinopathy, retinal detachments, Macular Hole, and Epiretinal membranes. Participants were also surveyed regarding their attitudes and perceptions about microscopes with the heads-up display system. Each of the survey question responses were then compared to contemporary literature, including evidence-based guidelines, randomized controlled trials, real-world evidence, and analogous international surveys. Comprehensive analysis related to this has been put forward in the article.

Conclusion: This survey represents the contemporary practice patterns among vitreoretinal specialists in India. The survey results are vital for fellow practitioners to understand the "standard of care" practice in surgical retina. This will guide them to devise the best possible individualized treatment strategy for most favorable clinical outcomes.
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http://dx.doi.org/10.4103/ijo.IJO_2877_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8302326PMC
June 2021

Vitreoretinal Society of India practice pattern survey 2020: Medical retina.

Indian J Ophthalmol 2021 06;69(6):1430-1439

Vitreoretinal Society of India (VRSI); Suven Clinical Research Center, LV Prasad Eye Institute, Hyderabad, Telangana, India.

Purpose: The aim of this study was to present the outcomes of the Vitreo-retinal Society of India (VRSI) Practice Pattern Survey 2020 in medical retina.

Methods: An online survey of members of VRSI was conducted in April 2020 regarding their practice-patterns on varied medical and surgical retina topics concerning imaging and management approach. The results were evaluated by two independent experts in this field and compared with the evidence and other practice patterns in the world.

Results: A total of 107 VRSI members participated in the online survey. Responses were obtained on management of wide-ranging chorioretinal disorders such as Central Serous Chorioretinopathy (CSCR), Polypoidal Choroidal Vasculopathy (PCV), Neovascular age related macular degeneration (n-AMD), Retinal Vein Occlusions (RVO), and Diabetic Retinopathy (DR). Participants were also surveyed regarding their attitudes and perceptions about anti-VEGF practice patterns and role of imaging in their current practice. Each of the survey question responses were then compared to contemporary literature, including evidence-based guidelines, randomized controlled trials (RCTs), real-world evidence and analogous international surveys. Comprehensive analysis related to this has been put forward in the article.

Conclusion: This survey represents the contemporary practice patterns amongst vitreoretinal specialists in India. The survey results are vital for fellow practitioners to understand the 'standard of care' practice in medical retina. This will guide them to devise the best possible individualized treatment strategy for most favorable clinical outcomes.
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http://dx.doi.org/10.4103/ijo.IJO_2573_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8302292PMC
June 2021

Commentary: COVID-19 and ocular inflammation: Where do we stand and where are we headed?

Authors:
Jay U Sheth

Indian J Ophthalmol 2021 May;69(5):1321-1322

Vitreo-Retina Consultant and Head of Research, Surya Eye Institute and Research Centre, Mumbai, Maharashtra; Clinical Research Lead, Chaitanya Eye Hospital and Research Institute, Trivandrum, Kerala, India.

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http://dx.doi.org/10.4103/ijo.IJO_671_21DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8186630PMC
May 2021

Real-World Safety Outcomes of Intravitreal Ranibizumab Biosimilar (Razumab) Therapy for Chorioretinal Diseases.

Ophthalmol Ther 2021 Jun 17;10(2):337-348. Epub 2021 Apr 17.

Department of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, 700120, India.

Introduction: To assess the safety profile of the intravitreal ranibizumab biosimilar molecule, Razumab (Intas Pharmaceuticals, Ahmedabad, India) in chorioretinal disorders under real-world conditions.

Methods: This was a multicenter, retrospective chart review which included patients from 15 centers receiving intravitreal Razumab (IVRz) injections from 2016 to 2020. Patient demographics, ocular examination data, and detailed safety information regarding serious adverse events (SAE) or serious adverse drug reactions (sADR), and non-serious AEs (nsAE) or non-serious ADRs (nsADR) occurring within 1 month of IVRz injections were compiled.

Results: A total of 6404 eyes of 6404 patients received 9406 IVRz injections [mean (± SD) = 1.49 (± 0.63)] during 4.25 years. Adverse events were reported after 1978 injections (21.03%): 64.16% nsAE, 32.96% nsADR, 2.37% sADR, and 0.51% SAE. The most frequent adverse events were subconjunctival hemorrhage (8.2% of total injections), transient blurring of vision (6.5% of total injections), and mild ocular pain (5.27% of total injections). Serious ocular (31 cases with retinal pigment epithelial tears [0.33%], two cases of non-infectious vitritis [0.02%], and one case of endophthalmitis [0.01%]) and systemic (seven patients with non-fatal myocardial infarction [0.12%] and six patients with non-fatal cerebrovascular accident [0.09%]) adverse events were infrequent.

Conclusion: The study reports the largest pooled safety data on IVRz use in a real-world scenario. The results did not raise any new ocular or systemic safety concerns for the biosimilar agent, with the incidence and spectrum of adverse reactions similar to those reported with other anti-vascular endothelial growth factor (anti-VEGF) drugs. The real-world evidence suggests that IVRz is a safe anti-VEGF agent in the management of chorioretinal disorders.
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http://dx.doi.org/10.1007/s40123-021-00345-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8079600PMC
June 2021

Changing trends in the use of anti-vascular endothelial growth factor (anti-VEGF) biosimilars: Insights from the Vitreoretinal Society of India Biosimilars of Anti-VEGF Survey.

Indian J Ophthalmol 2021 02;69(2):352-356

Department of Ophthalmology, Vitreoretinal Society of India (VRSI); Suven Clinical Research Center, L. V. Prasad Eye Institute, Hyderabad, Telangana, India.

Purpose: The aim of this study was to present the outcomes of the 2018 and 2020 Vitreo-retinal Society of India (VRSI) biosimilars of anti-vascular endothelial growth factor (VEGF) (VIBE) surveys.

Methods: An online survey of members of VRSI was conducted in July 2018 and January 2020 regarding their practice-patterns on anti-VEGF biosimilars pertaining to safety, efficacy, pricing, and need for enhanced clinical trials before regulatory approval.

Results: In 2018, 112 VRSI members participated, whereas in 2020, 98 society members participated. In both surveys, majority of respondents were aware of biosimilars (96%, 2018 vs. 100%, 2020; P = 0.9) and felt that approval of biosimilar drugs should be made more stringent with larger clinical trials (89%, 2018 vs. 91%, 2020; P = 0.93). An increase in use of ranibizumab-biosimilar (41%, 2018 to 56%, 2020; P = 0.2) and a simultaneous significant decline in use of bevacizumab-biosimilar (9%, 2018 to 2%, 2020; P = 0.04) was noted from 2018 to 2020. From 2018 to 2020, the proportion of respondents satisfied with safety (61% to 68%; P = 0.59) and efficacy (65% to 81%; P = 0.32) of ranibizumab-biosimilar increased. However, during the same period, we noted in reduction in satisfaction levels with safety of bevacizumab-biosimilar (30% to 25%; P = 0.54), whereas satisfaction with its efficacy was stable (29% vs 30%; P = 0.99). A substantial proportion of retina specialists considered that current cost of ranibizumab-biosimilar ($130) was sufficiently low for it to be used as a substitute for Avastin (37%, 2018 and 40%, 2020; P = 0.82).

Conclusion: The VRSI surveys reveal that Indian vitreoretinal specialists are familiar with anti-VEGF biosimilars. There was a progressive trend favoring ranibizumab-biosimilar over bevacizumab-biosimilar. One-third of the participants deem the current price of ranibizumab-biosimilar as appropriate to replace Avastin. Simultaneously, the need for enhanced pharmacovigilance and larger clinical trials are warranted for regulatory approval of these agents.
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http://dx.doi.org/10.4103/ijo.IJO_2703_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7933895PMC
February 2021

Commentary: Ocular changes after bariatric surgery - An evolving domain.

Authors:
Jay U Sheth

Indian J Ophthalmol 2021 02;69(2):306-307

Department of Vitreo-Retina, Surya Eye Institute and Research Centre, Mumbai, Maharashtra, India.

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http://dx.doi.org/10.4103/ijo.IJO_1973_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7933825PMC
February 2021

Response to comments on: Retinal vein occlusion in COVID-19: A novel entity.

Indian J Ophthalmol 2021 01;69(1):195-196

Department of Vitreoretinal Services, Surya Eye Institute and Research Center, Mumbai, Maharashtra, India.

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http://dx.doi.org/10.4103/ijo.IJO_3319_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7926163PMC
January 2021

Response to comments on: Retinal vein occlusion in COVID 19: A novel entity.

Indian J Ophthalmol 2021 01;69(1):193-194

General Secretary, Vitreoretinal Society of India; Suven Clinical Research Center, LV Prasad Eye Institute, Hyderabad, Telangana, India.

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http://dx.doi.org/10.4103/ijo.IJO_3221_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7926125PMC
January 2021

Commentary: Low incidence of pachydrusen in central serous chorioretinopathy in an Indian cohort.

Authors:
Jay U Sheth

Indian J Ophthalmol 2020 01;68(1):124-125

Department of Vitreo-Retina, Surya Eye Institute and Research Centre, Mumbai, Maharashtra, India.

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http://dx.doi.org/10.4103/ijo.IJO_1581_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6951160PMC
January 2020

Comment on: Validating the pachychoroid disease spectrum using multimodal imaging.

Indian J Ophthalmol 2019 02;67(2):310-311

Department of Vitreo-Retina, Giridhar Eye Institute, Cochin, Kerala, India.

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http://dx.doi.org/10.4103/ijo.IJO_1460_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6376840PMC
February 2019

CHARACTERIZATION OF MACULAR CHOROIDAL THICKNESS IN ISCHEMIC AND NONISCHEMIC DIABETIC MACULOPATHY.

Retina 2017 Mar;37(3):522-528

Department of Vitreo-Retina, Giridhar Eye Institute, Kochi, India.

Purpose: To evaluate changes in macular choroidal thickness in eyes with ischemic and nonischemic diabetic maculopathy.

Methods: Cross-sectional study of enhanced depth imaging optical coherence tomography of patients with diabetes. The diabetic eyes were divided into 3 groups: 1) eyes with no diabetic retinopathy (NDR); 2) those with diabetic retinopathy without macular ischemia (DR/MI-); and 3) those with diabetic retinopathy and macular ischemia (DR/MI+).

Results: This analysis included 261 eyes of 160 patients. Eighty-eight eyes belonged to the NDR, 90 to the DR/MI-, and 83 to the DR/MI+ group. The choroidal thickness was significantly reduced in the DR/MI+ group as compared with the other 2 groups in the subfoveal region (NDR: 285.94 ± 80.38 μm, DR/MI-: 311.22 ± 94.55 μm, DR/MI+: 216.06 ± 58.41 μm; P < 0.001), nasally and temporally (P < 0.01). Between the NDR and DR/MI- groups, the choroidal thickness was significantly reduced nasally (P = 0.02) in the NDR group, but not subfoveally (P = 0.1) and temporally (P = 0.2). Notably, no statistically significant difference in central macular thickness was found between the DR/MI- (328.68 ± 103.28 μm) and DR/MI+ (341.99 ± 130.63 μm) groups (P = 1), although it was found to significantly increase in both these groups as compared with the NDR group (264.03 ± 27.74 μm; P < 0.001).

Conclusion: In diabetic maculopathy, an overall significant reduction was observed in macular choroidal thickness in eyes in ischemic stage as compared with nonischemic stage. In vivo evaluation of choroidal structural changes in the form of choroidal thickness may possibly be intuitive in understanding the pathogenesis of progression of diabetic maculopathy from nonischemic to ischemic stage, and associated functional damage.
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http://dx.doi.org/10.1097/IAE.0000000000001172DOI Listing
March 2017

Persistent hyaloid artery with an aberrant peripheral retinal attachment: A unique presentation.

Oman J Ophthalmol 2013 Jan;6(1):58-60

Department of Vitreoretina, Lotus Eye Care Hospital, Coimbatore, Tamilnadu, India.

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http://dx.doi.org/10.4103/0974-620X.111924DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3678202PMC
January 2013
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