Aflibercept vs. dexamethasone implant for recalcitrant diabetic macular edema in pseudophakic eyes - 1-year outcomes from a quazi-randomized study in India.

PURPOSE: To assess the safety and efficacy of intravitreal Aflibercept (IVA) versus dexamethasone (DEX) implant for treating recalcitrant diabetic macular edema (DME) in pseudophakic eyes at 1-year follow-up. DESIGN: Retrospective comparative case series. PARTICIPANTS: Data of all patients diagnosed with DME between January 2019 and December 2021, who underwent 4-monthly doses of intravitreal ranibizumab but had persistent DME [central macular thickness (CMT) within 10% of baseline value] were extracted from a computerized database. Of these, only pseudophakic eyes that underwent either IVA or DEX implant and had at least 1-year follow-up were included for analysis. METHODS: DEX implant was preferred before December 2020 and IVA after this time point. In the IVA group, patients were followed up every month while DEX were followed at least every 3 months. Reinjections were considered when vision dropped by at least 1 Snellen's line or CMT increased by at least 10% from the previous visit in both groups. MAIN OUTCOME MEASURES: Comparison of change in vision and CMT at 1-year follow-up in DEX versus IVA groups. RESULTS: Eighty-four eyes of 84 patients aged 54.4 + 4.4 years were included, 39 (46%) received DEX and 45 (54%) received IVA. Groups were comparable for baseline vision and CMT. Vision improved equally in both groups from 0.83 + 0.15 logMAR to 0.52 + 0.10 logMAR at 3 months ( P < 0.01) and then stabilized till 1 year. However, eyes in the IVA group were 6.5 times more likely (Odds ratio = 6.45, 95% CI = 1.3 - 31.9) to achieve >3-line improvement in vision. The CMT reduction was also comparable between groups (-169 + 51 in DEX vs. -174 + 49 in IVA, P = 0.67). More eyes in the IVA group required >3 injections (91% vs. 69% in DEX, P = 0.01). The IOP was significantly higher at 6 and 9 months in the DEX group and 5 eyes (13%) required IOP lowering medications. CONCLUSION: In pseudophakic eyes with recalcitrant DME not responding to ranibizumab, switching to IVA or DEX implant results in equal visual improvement and CMT reduction. Though >3-line improvement occurs more frequently with IVA, this comes at the expense of a greater number of injections and follow-up visits.

Incidence, clinical features, risk factors, and outcomes of Intraocular inflammation following Brolucizumab in Indian eyes - A multicentric study.

Purpose: To report the incidence, clinical features, potential risk factors, and outcomes of intraocular inflammation (IOI) following brolucizumab in Indian eyes. Methods: All consecutive patients diagnosed with brolucizumab-induced IOI from 10 centers in eastern India between October 2020 and April 2022 were included. Results: Of 758 injections given during the study period across centers, 13 IOI events (1.7%) were recorded attributable to brolucizumab. The IOI occurred after the first dose in two eyes (15%) (median 45 days after brolucizumab), second dose in six eyes (46%) (median = 8.5 days), and third dose (39%) in the remaining five eyes (median 7 days). Reinjections of brolucizumab were administered at a median interval of 6 weeks (interquartile range = 4-10 weeks) in the 11 eyes, where IOI occurred after the second or third dose. Eyes that experienced IOI after the third dose had received a significantly greater number of previous antivascular endothelial growth factor injections (median = 8) compared to those who developed it after the first or second dose (median = 4) (P = 0.001). Anterior chamber cells were seen in almost all eyes (n = 11, 85%), while peripheral retinal hemorrhages were seen in two eyes, and one eye showed branch artery occlusion. Two-thirds of patients (n = 8, 62%) recovered with a combination of topical and oral steroids, while remaining recovered with topical steroids alone. Irreversible visual loss was not seen in any eye, and median vision recovered to pre-IOI levels by 3 months' time point. Conclusion: Brolucizumab-induced IOI was relatively rare, occurring in 1.7% of eyes, was more common after the second or third injection, especially in those who required frequent reinjections every 6 weeks, and occurred earlier with increasing number of previous brolucizumab injections. Continued surveillance is necessary even after repeated doses of brolucizumab.

Real-world outcomes and complications of different surgical approaches for significant submacular haemorrhages.

Purpose: To evaluate the outcomes and complications after different surgical management of cases with significant sumacular hemorrhage (SMH) of size more than 4 disc diameter (DD). Methods: It was a retrospective interventional study. All consecutive 103 cases of significant SMHs were treated by vitrectomy and divided into three groups. In Group A (<4 weeks, confined to the macula or extending inferiorly, n = 62), vitrectomy, subretinal cocktail of tissue plasminogen activator (tPA), antivascular endothelial growth factor, and air with SF6 gas; in Group B (4-8 weeks, extending beyond macula, n = 31), subretinal tPA followed by SMH drainage either by retinotomy (Group B-1, n = 17) or by temporal 180-degree retinectomy (Group B-2, n = 14) with silicone oil (SO) tamponade; and in Group C (>8 weeks, extending beyond macula, n = 10), SMH removal with autologous retinal pigment epithelium (RPE)-Choroid patch graft transplantations with SO tamponade were performed. Parameters evaluated were best corrected visual acuity (BCVA), Optos, optical computerized tomography, and ultrasonography as required. Results: Significant visual improvement was seen from mean preoperative to mean postoperative BCVA in Group A (P < 0.001), Group B (P < 0.001), and Group C (P < 0.001). Postoperative complications were recurrent SMH (4.84% vs 12.90% vs 10%), vitreous hemorrhage (6.45%, GroupA), hyphema (4.84% vs 12.90% vs 10%), hypotony (nil vs 3.23% vs 20%), macular hole formation (6.45%, Group A), epiretinal membrane (16.13%, Group B), and retinal detachment (3.23%, Group A and 10%, Group C). Conclusion: Surgical approaches for significant submacular hemorrhage are visually awarding, though certain specific complications may arise.

Biosimilar versus InnovAtor MoLecule of RAnibizumab in Neovascular Age-Related MaCular DEgeneration (The BALANCE Trial): Real-World Evidence.

Purpose: To analyse outcomes of innovator ranibizumab (IRM) (Lucentis) and biosimilar ranibizumab (BRM) (Razumab) in Indian eyes with neovascular age-related macular degeneration (nAMD). Methods: Retrospective observational study in nAMD patients, who were treated with IRM or BRM (3 loading doses followed by pro re nata (PRN). Primary outcome measures were change in best corrected visual acuity (BCVA) and central macular thickness (CMT) along with safety analysis. Secondary outcomes measures were changes in the subretinal fluid (SRF) and intraretinal fluid (IRF). Results: Inclusion criteria were satisfied in 164 eyes (60.74%). A total of 87 eyes were treated with IRM, and 77 eyes received BRM. Baseline BCVA was 0.57±0.27 logMAR in IRM group and 0.61±0.25 in the BRM group. At 3, 6, 9, and 12 months BCVA was 0.27±0.22 (p<0.0001), 0.34±0.23 (p<0.0001), 0.39±0.25 (p<0.0001), and 12 months 0.41±0.23 (p<0.0001) in the IRM group and 0.24±0.16 (p<0.0001), 0.27±0.16 (p<0.0001), 0.34±0.17 (p<0.0001), 0.38±0.18 (p<0.0001) in the BRM group. Baseline CMT was 420.39±54.45 µm in IRM group and 407.82±53.07 µm in BRM group. At 3, 6, 9, and 12 months, CMT decreased to 258.28±20.4 µm (p<0.0001), 268.38±19.5 µm (p<0.0001), 269.51±32.41 µm (p<0.0001), and 278.28±16.56 µm (p<0.0001) in the IRM group and 258.84±17.47 µm (p<0.0001), 265.69±17.29 µm (p<0.0001), 273.64±23.13 µm (p<0.0001), and 283.09±19.66 µm (p<0.0001) in the BRM group. Similar improvements in IRF and SRF levels in the patients were noted in both groups. Required number of doses of IRM and BRM was similar over the 12 month period in both groups. A similar profile of adverse events was noted in both the groups. Conclusion: Intravitreal injection of IRM and BRM show similar efficacy and safety in Indian eyes with nAMD.

Role of Small-Gauge Proportionate Reflux-Assisted Hydrodissection In Elevated Symptomatic Vitreofoveal Traction.

BACKGROUND/PURPOSE: To describe a new technique to release the elevated symptomatic vitreofoveal traction. METHODS: This was a retrospective, interventional case series where a new technique of hydrodissection by proportionate reflux property of small-gauge vitrectomy cutter was used in cases of elevated symptomatic vitreofoveal traction as evident on optical coherence tomography. After vitrectomy, an opening was made in the taut posterior hyaloid face around the foveal elevation. Then, the cutter tip was insinuated inside the hyaloid opening, and the port opening was directed toward the tip of the fovea at its hyaloid attachment. The proportionate reflux property of the cutter was then used to cause reflux of cassette fluid. The hydrostatic force thus generated separates the vitreofoveal attachment. End point was separation of vitreofoveal traction. RESULTS: Seven eyes of seven patients were operated by 27-gauge (n = 3) or 25-gauge (n = 4) vitrectomy system. Mean preoperative and postoperative BCVA were LogMAR 0.44 (20/55) ± 0.14 and LogMAR 0.27 (20/37) ± 0.11, respectively ( P = 0.23). Mean preoperative foveal elevation was 560.86 ± 196.57 µ m, which significantly decreased postoperatively to 251 ± 79.13 µ m ( P < 0.01). VMTs were successfully released in all cases. Mean follow-up was 184.00 ± 80.32 days. CONCLUSION: Small-gauge proportionate reflux-assisted hydrodissection is an innovative technique for management of elevated symptomatic cases of vitreofoveal traction.

Combined Internal Limiting Membrane Peeling and Subretinal Balanced Salt Solution Injection: A Novel Technique to Unfold Congenital Falciform Folds.

PURPOSE: To describe a novel surgical technique to unfold congenital falciform folds. METHOD: A retrospective, interventional case series was performed where a novel technique was applied to treat five cases of congenital falciform folds. Twenty-five-gauge vitrectomy was performed along with the removal of all vitreous adhesions. The internal limiting membrane was peeled from the macula and around the macular fold area. A Tano diamond-dusted membrane scraper was used to stretch the folded retina mechanically. Then, subretinal balanced salt solution was injected using a 38-gauge subretinal needle to create multiple blebs around the folded retina. Finally, 20% sulfur hexafluoride gas was used for tamponade. Follow-up was conducted for a minimum of 6 months. RESULTS: Vision improved from preoperative mean best-corrected visual acuity logMAR 1.44 (20/550) ± 0.32 to postoperative mean best-corrected visual acuity logMAR 0.75 (20/112) ± 0.17 ( P value = 0.0208) after intervention. There was a reduction in the macular fold. Postoperatively, a macular hole with retinal detachment developed in one of five (20%) eyes. CONCLUSION: The novel technique of vitrectomy with combined internal limiting membrane peeling and subretinal balanced salt solution injection is visually rewarding in treating congenital falciform folds.

Complete manuscript title: role of sub-silicone oil application of triamcinolone acetonide (TA) drops on outcomes after 360° relaxing retinectomy: a pilot study.

PURPOSE: To perform a pilot study to evaluate the role of sub-silicone oil Triamcinolone Acetonide (TA) crystal drops in complex Retinal Detachment (RD) with extreme proliferative vitreoretinopathy (PVR) requiring 360-degree relaxing retinectomy (RR). DESIGN: It was a retrospective pilot study. MATERIALS AND METHODS: It was a retrospective case-control pilot study. TA-assisted 23G or 25G vitrectomy was done in 24 complex RDs with extreme PVR where 360 degree RR had to be performed. Group A (n = 13) included cases where additional TA crystal drops were applied, after settling the detached retina, over the site of RR under silicone oil (SO 5000 CSt) tamponade. In the control arm, group B (n = 11), additional TA crystals were not applied. MAIN OUTCOMES MEASURED: Mean pre- and post-operative BCVA, ultra-widefield fundus photograph by Optos 200Tx, macular OCT and the propensity to remove silicone oil were measured. RESULTS: Mean pre-operative and post-operative BCVA at final follow-up were Log MAR 2.69 ± 0.41 and Log MAR 1.51 ± 0.90 (Mann-Whitney U test, p < 0.05), respectively, in Group A and Log MAR 2.9 and Log MAR 2.37 ± 0.86 (Mann-Whitney U test, p < 0.05), respectively, in group B. Visual improvement in group A was significantly better than group B (Wilcoxon W test, p < 0.025) with significantly less recurrence of RD (Fisher's Exact Test, p = 0.002). Silicone oil removal was done significantly more in group A (Fisher's Exact Test, p = 0.0017). CONCLUSION: Sub-silicone oil crystals application over sites of RR after 360-degree relaxing retinectomy leads to improved postoperative visual recovery as well as improved anatomical outcomes with fewer complications.

Intravitreal Injection of Brolucizumab for Recalcitrant Macular Edema due to Central Retinal Vein Occlusion: A Small Case Series.

This was a single center, prospective uncontrolled nonrandomized case series. Two eyes with recalcitrant ME secondary to CRVO, who have received a minimum of ten intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections, underwent IVI brolucizumab (BRZ). Patients underwent best corrected visual acuity (BCVA) testing, ophthalmic examination, and optical coherence tomography at baseline and follow-up visits (weeks 4, 8, 12, and 16). Both patients demonstrated notable improvement in BCVA and reduction of fluid on SD-OCT lasting up to week 12. At week 16, though both the eyes maintained the visual acuity gains, early increase in fluid was noted in both cases, for which second dose of IVI BRZ was given. No ocular or systemic adverse events were noted in these 2 cases.

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

Purpose: To report the 52-week real-world efficacy and safety outcomes of brolucizumab therapy for neovascular age-related macular degeneration (nAMD) in Indian eyes. Patients and Methods: A retrospective, multicentre chart analysis of 82 eyes of 82 patients with nAMD (switch therapy: 65 eyes; treatment-naïve: 17 eyes) with 52-week follow-up data was performed. Pro-re-nata re-treatment was offered based on visual and tomographic criteria. Changes in best-corrected visual acuity (BCVA), intraretinal fluid (IRF), subretinal fluid (SRF), central-subfield thickness (CST), and pigment epithelial detachment (PED) were the key outcome measures, coupled with the safety profile. Results: The mean age of the study population was 67.65 (±10.67) years, with 57 male patients (69.5%). The study's mean number of injections was 4.8 (± 0.77). After brolucizumab therapy, the BCVA improved significantly at weeks 4 (P<0.001), and maintained up to week 52 (P<0.001). The CST also reduced significantly at all the visits (Baseline: 413.6 ± 64.6 µm; 52-week: 292.37 ± 13.5 µm; P<0.001). Significantly fewer eyes demonstrated residual SRF (P<0.001) and IRF (P<0.001) at all visits, starting with week 12 and continuing until week 52. The PED resolution was significant from week 24 through week 52 (P=0.004). Each of the 82 eyes received four injections of brolucizumab, with 63.4% (52 eyes) receiving a fifth dose and only 17.1% requiring a sixth. Mild intraocular inflammation (IOI) was seen in three eyes (3.66%) that resolved conservatively. One patient (1.2%) developed mild fever that subsided with oral medications. Conclusion: The 52-week BRAILLE study demonstrates that brolucizumab is effective and safe in nAMD eyes in a real-world setting. Brolucizumab treatment can reduce the therapeutic burden in patients with nAMD due to its rapid, sustained efficacy and favourable safety profile.

Rhegmatogenous retinal detachment following femtosecond laser-assisted cataract surgery.

Rhegmatogenous retinal detachment (RRD) following femtosecond laser-assisted cataract surgery (FLACS) has not been reported till date. We described the first case of RRD after FLACS. A 29-year-old male presented with complaints of sudden, painless dimness of vision in the left eye (LE) for the past 2 days. He was operated for refractive lens exchange in both eyes for high myopia using FLACS 3 months back. On examination, his LE vision was perception of light and accurate projection of rays with fundus showing bullous RRD. His right eye fundus was absolutely normal with 20/20 vision. A 25-gauge vitrectomy was performed in LE. The retina was settled with silicone oil (1300 centistokes) endotamponade. After 4 weeks, the patient gained 20/60 vision in LE with attached retina under silicone oil. RRD is a potential complication following FLACS and thus frequent follow-ups are required for high-risk patients after FLACS.

Unfolding falciform folds and their consequences - To touch or not to touch.

BACKGROUND: Falciform folds are congenital tractional retinal folds due to strong contractile forces and hyperextensibility of retina resulting in temporal dragging of the macula and often associated with familial exudative vitreoretinopathy and retinal detachment (RD). Retinologists are reluctant to treat these entities in view of their poor visual recovery. PURPOSE: To describe a novel surgical technique to unfold the falciform folds. SYNOPSIS: This video demonstrates innovative surgical techniques to remove both pre-retinal and sub-retinal adhesions and unfold these folds, managing its consequences and visual recovery. We describe cases of congenital falciform folds with poor visual acuity, where we did vitrectomy, membrane adhesion removal, peeling of the internal limiting membrane (ILM) the macula, mechanical stretching of the folded retina by Tanno scraper or Finesse flex loop, then sub-retinal injection of balanced salt solution (BSS) by 38 gauge sub-retinal needleo create multiple blebs around the folded retina and finally sulphur hexafluoride tamponade. Post-operative macular hole with RD can be a complication. When this falciform fold is complicated by RD, there is risk of intraoperative subretinal migration of infusion cannula and therefore the need for peripheral relaxing retinectomy for redundant retinal fold as well as silicone oil as endotamponade. Vision improved in all our patients after the surgery. HIGHLIGHTS: Both long-standing pre-retinal adhesions as well assub-retinal adhesions are responsible for he tformation of congenital falciform folds. For pre-retinal adhesions, vitrectomy with removal of all the adhesions along with peeling of the sticky ILM and then mechanical stretching of folded retina by Tanno scraper or Finesse flex loop are necessary. To remove sub-retinal adhesions, sub-retinalinjection of BSS is necessary to stretch the folded retina from behind, but it should be done away from the retina to avoid formation of macular hole. ONLINE VIDEO LINK: https://youtu.be/9h8IE3abKIM.

Role of intravitreal brolucizumab with intravitreal rtPA and pneumatic displacement for submacular hemorrhage: A case series.

PURPOSE: To evaluate the role of intravitreal injection (IVI) of brolucizumab along with intravitreal recombinant tissue plasminogen activator (rtPA) and C3F8 gas injection for large submacular hemorrhage (SMH) secondary to neovascular age-related macular degeneration (nAMD). OBSERVATIONS: This was a prospective uncontrolled non-randomized case series conducted at a single site. Three patients with fresh SMH (≤4 days) secondary to nAMD underwent triple therapy with IVI brolucizumab + intravitreal rtPA (50 µg in 0.1 mL) + 0.3 mL of 100% C3F8 gas injection. Post-injection, a face-down position was advised for 5 days with periodic follow-up visits. All three patients had complete resolution of SMH at the end of 4 weeks with a notable improvement in the best-corrected visual acuity (BCVA). No optical coherence tomographic (OCT) biomarkers of disease activity were noted at the end of 12 weeks in the first and the third case and 4 weeks in the second case respectively. There were no ocular or systemic side effects reported in any of the cases. CONCLUSIONS AND IMPORTANCE: Intravitreal brolucizumab administered along with intravitreal rtPA and C3F8 gas injection was found to be efficacious and safe for the management of large SMH secondary to nAMD. Complete displacement of SMH with excellent structural and functional outcomes can be seen with triple therapy.

Comparison of Innovator vs. Biosimilar Ranibizumab in Treating Diabetic Macular Edema: A Multicenter Retrospective Study.

INTRODUCTION: To compare the efficacy of innovator ranibizumab (iRBZ-Accentrix, Novartis, India) vs. biosimilar ranibizumab (bRBZ, Razumab-Intas, India) in eyes with diabetic macular edema (DME) in an Indian population. METHODS: Data of patients with DME who underwent at least three injections of iRBZ or bRBZ and had a minimum of 6 months follow-up were obtained from an electronic database. Choice of injection depended upon the patient. Pro re nata (PRN) protocol from baseline was used with reinjections advised if the central macular thickness (CMT) was at least 300 µm and best corrected visual acuity (BCVA) was 20/40 or worse. Primary outcome measure was comparison of change in BCVA at 6 months between iRBZ and bRBZ. RESULTS: We included 264 eyes in the iRBZ group and 69 eyes in bRBZ group, which were comparable for baseline characteristics. Mean BCVA improved from 0.64 ± 0.39 logMAR to 0.47 ± 0.31 logMAR (p < 0.001) in the iRBZ group and from 0.71 ± 0.42 logMAR to 0.50 ± 0.29 logMAR in the bRBZ group (p < 0.001) at 6 months. There were no differences in BCVA between the two groups (p > 0.05 for all time points). The CMT reduction in the iRBZ group (120 ± 196 µm) was comparable to that in the bRBZ group at 6 months (105 ± 187 µm) (p = 0.69). There was no difference in the mean number of injections taken (3.81 ± 1.2 in iRBZ vs. 3.55 ± 1.2 in bRBZ) (p > 0.05) between groups. Vision at baseline was the only factor associated with vision at last follow-up after adjusting for CMT at baseline, type of injection, and number of injections. CONCLUSIONS: Biosimilar RBZ is similar to innovator RBZ in improving vision and reducing CMT in eyes with DME in the short term.

Modified posterior drainage of post-operative suprachoroidal hemorrhage.

PURPOSE: To study the anatomical and functional outcomes of trans-conjunctival 23G or 25G cannula-guided modified posterior passive drainage of post-operative suprachoroidal hemorrhage (SCH). METHODS: A retrospective study was done on 15 eyes in the last nine years. Vitrectomy with perfluorocarbon liquid injection to push SCH from inside along with 23G or 25G cannula-guided passive drainage of SCH was performed by making multiple sutureless posterior sclerotomies at 10-15 mm behind the limbus. Postoperatively, best corrected visual acuity (BCVA), intraocular pressure (IOP), and posterior segment findings were compared from pre-operative findings. RESULTS: Mean age at presentation was 64.93 ± 7.62 years. Complete resolution of SCH with attached retina was achieved in 60% (9/15) of cases. Mean pre-operative BCVA of Log MAR 2.82 ± 0.21 improved to mean post-operative BCVA Log MAR 1.04 ± 0.53 (P < 0.001). Mean pre-operative IOP of 27.87 ± 8.67 mmHg improved significantly to post-operative IOP of 10.2 ± 5.16 mmHg (P < 0.001). Silicone oil removal was possible in 11/15 (73.33%) cases. CONCLUSION: Posterior passive drainage of post-operative SCH by multiple sclerotomies using 23G or 25G cannulas can salvage these eyes with both anatomical and functional recovery.

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

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.

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

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.

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

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.

A novel video overlay guided enlargement of area of ILM peeled versus inverted flap technique: A long-term study in large macular holes.

BACKGROUND/AIM: To compare the intra-operative video overlay guided enlargement of Area of ILM peeled (AIP) more than three Disc Diameter (DD) versus the inverted flap technique in large (>400 µm ) Full Thickness Macular Holes (FTMH). METHODS: Retrospectively, 127 cases of large FTMHs divided into two groups (i) Group A (n = 62)-intra-operative video-overlay guided enlargement of AIP > 3DD performed and (ii) Group B (n = 65)-Inverted flap technique was done. Mean Best Corrected Visual Acuity (BCVA), hole closure rate and postoperative foveal anatomy were noted on Optical Coherence Tomography (OCT). RESULTS: Mean Minimal Diameter of Macular Hole (MDMH) were 632.05 ± 146.62 µm (A) and 677.24 ± 152.08 µm (B). Hole closure rate were 93.55% (A) and 96.92% (B). Mean preoperative BCVA was 1.07 ± 0.37 Log MAR (A) and 0.94 ± 0.23 Log MAR (B). Mean postoperative BCVA at 3 months were 0.73 ± 0.22 Log MAR (A) and 0.83 ± 0.24 Log MAR (B). One-way ANOVA test showed statistically better visual improvement in Group A at 3 months (p = 0.02), 6 months (p = 0.045), 12 months (p = 0.002), and 24 months (p = 0.011). Chi square test revealed Type I pattern of hole closure was statistically more in Group B (p < 0.001). Delayed Recovery of Outer Retinal Layers was more in group B (Pearson Chi square test, p = 0.039). CONCLUSION: Anatomically, macular hole closure rate as well as closure pattern was better in Group B. But functional improvement was better in Group A.

Long-term clinical outcomes of submacular blood removal with isolated autologous retinal pigment epithelium-choroid patch graft transplantation in long-standing large-sized submacular hematomas: An Indian experience.

Purpose: To study the outcomes of submacular blood removal with isolated autologous full-thickness retinal pigment epithelial (RPE)-choroid patch graft transplantation in long-standing large-sized submacular hematomas in Indian population. Methods: A retrospective study was done on eight consecutive patients of long-standing large-sized submacular hematoma from east India. In all cases, 23G vitrectomy was performed with the induction of retinal detachment (performed with or without 38G or 41G subretinal cannula) and a temporal 180° retinectomy was done. Submacular blood along with choroidal neovascular tissue was removed. A full-thickness RPE-choroid autologous patch graft was taken from a relatively healthy quadrant at the mid periphery and then the graft transferred under perfluorocarbon liquid (PFCL) to place it in the subfoveal area. Then, retina was re-attached using PFCL and laser completed. Silicone oil (5000 cst) was used as a tamponade. Post-operatively, wide-field fundus photographs (Optos), serial optical coherence tomography (OCT), indocyanine green angiography (ICGA), and multifocal electroretinography (ERG) were done. Results: The mean age of the patients at presentation was 67.88 ± 10.03 years. Mean pre-operative best corrected visual acquity (BCVA) was 2.64 ± 0.3 log MAR and mean postoperative BCVA was 1.095 ± 0.27 log MAR (P < 0.05). The mean follow-up was 20 ± 16.57 months. ICG showed re-vascularization of translocated graft in all at 2 months. Multifocal ERG (after 6 months) showed some waveform in all. None of the cases developed re-bleed. Conclusion: Removal of submacular blood and neovascular membrane with autologous RPE-choroid graft is a viable option in cases with long-standing large submacular hematomas.