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.

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.

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.

Severe Vaso-Occlusive Retinopathy in Systemic Lupus Erythematosus: A Case Series.

This study aims to describe the clinical profile of severe vaso-occlusive retinal disorders in patients with systemic lupus erythematosus (SLE) and it is a retrospective case series. The clinical characteristics of three patients with SLE with vascular occlusions in four eyes were described. Branch retinal artery occlusion (BRAO) was present in all three patients with combined non-ischemic central retinal vein occlusion (NICRVO) in one patient and evolving ischemic CRVO in another patient. Additional branch retinal artery insufficiency was observed in the other eye of a patient with BRAO. Antinuclear antibody (ANA) titer was elevated in all patients. One patient had a positive lupus anticoagulant with elevated activated partial thromboplastin time (aPTT), and concurrent homocysteinemia was present in another patient. Intravitreal anti-vascular endothelial growth factor (ranibizumab) injection was administered to two eyes. Intravenous methyl prednisolone (IVMP) injection along with oral azathioprine was used in all patients with the need for anticoagulation in two patients along with SLE treatment. Vision in two eyes did not improve to the functional level despite aggressive therapy. Visually blinding severe vaso-occlusive retinopathy in the form of BRAO with or without CRVO can manifest in patients with SLE. Undetected antiphospholipid syndrome and homocysteinemia may be associated risk factors for such ophthalmic complications.

A novel standardized reproducible method to calculate the area of internal limiting membrane peeled intra-operatively in macular hole surgery by using a video overlay-A long-term study in cases of idiopathic macular holes.

Purpose: To calculate AIP and to find correlation between hole closure pattern with AIP in idiopathic full thickness macular hole (FTMH) cases. Methods: In this prospective, non-randomized, interventional single blind study, 105 eyes of symptomatic FTMH (<6 month duration) were operated. Minimal diameter of macular hole (MDMH) was calculated on OCT, divided into Group I (>400µ, n = 75) and Group II (<400µ, n = 30). 23G vitrectomy with ILM peeling and gas injection were done in all and recorded. Final area of ILM peeled (AIP) was calculated using Adobe Photoshop CS2 (PSD format) in disc diameters (DD) from still frame. Follow up was done at 6 monthly interval up to a maximum of 5 years after surgery. Results: Macular holes were closed in 92.38% eyes. In Group I, mean pre-operative BCVA was 1.14 ± 0.39 log MAR and was improved to 0.79 ± 0.26 log MAR post-operatively at 6 months. In Group II, mean pre-operative BCVA was 0.95 ± 0.44 log MAR and was improved to 0.60 ± 0.24 log MAR after surgery. When AIP was more than 3DD, Type I and Type II closure were 72.77% and 27.27% in Group I (P value <0.01) and 84.21% and 15.79% in Group II (P value <0.01). Conclusion: AIP can be calculated using Adobe Photoshop CS2. Type I closure was significantly high with AIP >3DD in both groups. Intra-operatively using video overlay, surgeons can increase the diameter of AIP to get better closure pattern.

Intravitreal live Gnathostoma spinigerum.

Intraocular infestation by live Gnathostoma spinigerum is a rare occurrence in humans. Most of the published reports are from South-East Asia. We report a case of intravitreal gnathostomiasis, where the worm was removed live and intact by pars plana vitrectomy.