Vitrectomy as an Adjunct to Treat-and-Extend Anti-VEGF Injections for Diabetic Macular Edema: The Vitrectomy in Diabetic Macular Oedema (VIDEO) Randomized Clinical Trial.

Importance: There are reported benefits from vitrectomy for diabetic macular edema (DME); however, data precede anti-vascular endothelial growth therapy (VEGF) therapy, supporting a need to assess the current role of vitrectomy. Objective: To determine rates of recruitment and efficacy outcomes of vitrectomy plus internal limiting membrane (ILM) peeling adjunctive to treat-and-extend (T&E) anti-VEGF injections for diabetic macular edema (DME). Design, Setting, and Participants: This was a single-masked, multicenter randomized clinical trial at 21 sites in the United Kingdom from June 2018 to January 2021, evaluating single eyes of treatment-naive patients with symptomatic vision loss from DME for less than 1 year. Inclusion criteria were best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study letter score greater than 35 (approximate Snellen equivalent, 20/200 or better) and central subfield thickness (CST) greater than 350 µm after 3 monthly intravitreal injections of ranibizumab or aflibercept. Data analysis was performed in July 2023. Interventions: Patients were randomized 1:1 into vitrectomy plus standard care or standard care alone and further stratified into groups with vs without vitreomacular interface abnormality. Both groups received a T&E anti-VEGF injection regimen with aflibercept, 2 mg, or ranibizumab, 0.5 mg. The vitrectomy group additionally underwent pars plana vitrectomy with epiretinal membrane or ILM peel within 1 month of randomization. Main Outcomes and Measures: Rate of recruitment and distance BCVA. Secondary outcome measures were CST, change in BCVA and CST, number of injections, rate of completed follow-up, and withdrawal rate. Results: Over 32 months, 47 of a planned 100 patients were enrolled; 42 (89%; mean [SD] age, 63 [11] years; 26 [62%] male) completed 12-month follow-up visits. Baseline characteristics appeared comparable between the control (n = 23; mean [SD] age, 66 [10] years) and vitrectomy (n = 24; mean [SD] age, 62 [12] years) groups. No difference in 12-month BCVA was noted between groups, with a 12-month median (IQR) BCVA letter score of 73 (65-77) letters (Snellen equivalent, 20/40) in the control group vs 77 (67-81) letters (Snellen equivalent, 20/32) in the vitrectomy group (difference, 4 letters; 95% CI, -8 to 2; P = .24). There was no difference in BCVA change from baseline (median [IQR], -1 [-3 to 2] letters for the control group vs -2 [-8 to 2] letters for the vitrectomy group; difference, 1 letter; 95% CI, -5 to 7; P = .85). No difference was found in CST changes (median [IQR], -94 [-122 to 9] µm for the control group vs -32 [-48 to 25] µm for the vitrectomy group; difference, 62 µm; 95% CI, -110 to 11; P = .11). Conclusions and Relevance: Enrollment goals could not be attained. However, with 47 participants, evidence did not support a clinical benefit of vitrectomy plus ILM peeling as an adjunct to a T&E regimen of anti-VEGF therapy for DME. Trial Registration: isrctn.org Identifier: ISRCTN59902040.

Comparison between different techniques for treatment of submacular haemorrhage due to Age-Related Macular Degeneration.

PURPOSE: To compare the outcome of vitrectomy, subretinal tissue plasminogen activator (TPA), and gas with and without subretinal air versus Intravitreal TPA and gas in the treatment of submacular haemorrhage (SMH) due to Neovascular age related macular degeneration. METHODS: We analysed the notes of 29 cases presented with SMH in the period between 01/2016 and 09/2018 at James Cook University Hospital. Presenting visual acuity (BCVA), size and location of SMH, Procedure done, final BCVA at 6 months and any surgical complications were recorded. 11 Cases (Group 1) received intravitreal TPA (50 µg in 0.1 ML), 0.3 ml of pure sulfur hexafluoride (SF6). 18 cases (Group 2) received 23 G Pars Plana vitrectomy, Subretinal TPA injection (25 µg in 0.1 ml), and 20% SF6 gas filling. Group 2 was further divided into 2A (10 patients) who received only subretinal TPA and group 2B (8 patients) who received additional 0.1 ml subretinal air. RESULTS: The mean BCVA at presentation was 0.0068 in group 1 and 0.0067 in group 2 (p = 0.8734). The mean postoperative BCVA at 6 months was 0.31 in group 1 and 0.58 in group 2 (p = 0.0015). Subgroup analysis of group 2 didn't show statistically significant difference in outcome when adding subretinal air to the vitrectomy procedure (p = 0.7009). CONCLUSION: Vitrectomy, gas and subretinal TPA has more successful displacement rate and better visual outcome than Intravitreal TPA & Gas alone in treating SMH involving the fovea in age-related macular degeneration. Additional subretinal air doesn't seem to improve the outcome in cases having vitrectomy.

Diabetic macular edema outcomes in eyes treated with fluocinolone acetonide 0.2 µg/d intravitreal implant: real-world UK experience.

PURPOSE: To conduct an observational, multicenter study to evaluate real-world clinical efficacy and safety of the 0.2 µg/day fluocinolone acetonide (FAc) implant in the treatment of patients with chronic diabetic macular edema (DME) in 3 large hospital ophthalmology departments in the United Kingdom. METHODS: Fluocinolone acetonide implants were inserted into the study eyes following a suitable washout period; phakic eyes received FAc implant following cataract surgery. Follow-up visits took place 2-4 weeks postinjection and then at 3, 6, and 12 months; change in central macular thickness (CMT) from baseline was measured by optical coherence tomography and best-corrected visual acuity (BCVA) was also assessed. Adverse events and changes in intraocular pressure (IOP) were recorded in order to evaluate the safety profile for the FAc implant. RESULTS: Improvements in BCVA and CMT were observed from 3 months and sustained for the duration of observation. At 12 months, the overall mean change from baseline CMT was -126 µm and mean increase in BCVA from baseline was 5.1 letters. Increases in IOP following FAc implant were easily managed with IOP-lowering medication. Implant migration into the anterior chamber occurred in 2 eyes where prior vitrectomy had resulted in a posterior capsule defect; this was rectified and resolved. CONCLUSIONS: The results of this study provide further efficacy and safety profile data for FAc implant treatment of chronic DME in a real-world clinical setting; the FAc implant appears to be a valuable therapeutic approach for patients with chronic DME who have suboptimal response to other treatment options.

Progressive retinal detachment secondary to juxtapapillary microholes in association with type 3 posterior staphylomas.

PURPOSE: This study describes a novel subtype of retinal detachment occurring in eyes with pathological myopia associated with type 3 posterior staphyloma and discusses the management options. METHODS: We retrospectively reviewed the case notes of seven patients who presented with unilateral symptomatic rhegmatogenous retinal detachment secondary to nasal juxtapapillary microholes. RESULTS: All seven patients had pathological myopia and an associated peripapillary type 3 posterior staphyloma. They all presented with symptoms of acute posterior vitreous detachment and had progressive retinal detachment. All cases were discovered to have a single juxtapapillary hole less than 1 disc diameter from the optic-nerve head, within areas of nasal chorioretinal atrophy. The microholes were identified intraoperatively in six of seven cases, with one case identified preoperatively on optical coherence tomography. In the four most recent cases, successful retinal reattachment was achieved with vitrectomy and C2F6 gas tamponade. The remaining three cases were managed with vitrectomy and silicone oil. CONCLUSION: Seven patients with pathological myopia, type 3 posterior staphyloma, and progressive retinal detachment secondary to juxtapapillary microholes are presented in this paper. High clinical suspicion is required to identify these breaks. Successful retinal reattachment with pars plana vitrectomy and long-acting gas is possible.