Visual Acuity, Vitreous Hemorrhage, And Other Ocular Outcomes After Vitrectomy Vs Aflibercept For Vitreous Hemorrhage Due To Diabetic Retinopathy A Secondary Analysis Of A Randomized Clinical Trial

This secondary analysis of a randomized clinical trial compares exploratory outcomes between treatment groups that may affect treatment choices for patients with vitreous hemorrhage due to proliferative diabetic retinopathy.Importance Although there were no differences in mean visual acuity (VA) over 24 weeks after vitrectomy with panretinal photocoagulation (PRP) vs aflibercept in a randomized clinical trial among eyes with vitreous hemorrhage due to proliferative diabetic retinopathy (PDR), post hoc analyses may influence treatment choices. Objective To compare exploratory outcomes between treatment groups that may affect treatment choices for patients with vitreous hemorrhage due to PDR. Design, Setting, and Participants This post hoc analysis of a randomized clinical trial conducted at 39 DRCR Retina Network sites included adults with vision loss due to PDR-related vitreous hemorrhage for whom vitrectomy was considered. Data were collected from November 2016 to January 2020. Interventions Random assignment to 4 monthly injections of aflibercept vs vitrectomy with PRP. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol-specific criteria. Main Outcomes and Measures Visual acuity area under the curve (adjusted for baseline VA) and clearance of vitreous hemorrhage. Results A total of 205 eyes were included in the analysis (115 male [56%] and 90 [44%] female participants; mean [SD] age, 57 [11] years). Among 89 eyes with a baseline VA of 20/32 to 20/160 (47 receiving aflibercept, including 4 [9%] that had undergone vitrectomy; 42 undergoing vitrectomy, including 3 [7%] that had received aflibercept), the adjusted mean difference in VA letter score over 24 weeks between the aflibercept and vitrectomy groups was -4.3 (95% CI, -10.6 to 1.9) compared with -16.7 (95% CI, -24.4 to -9.1) among 59 eyes with baseline VA worse than 20/800 (P = .02 for interaction; 26 in the aflibercept group, including 6 [23%] that had undergone vitrectomy; 33 in the vitrectomy group, including 8 [24%] that had received aflibercept). In the full cohort, the median time to clearance of the initial vitreous hemorrhage was 36 (interquartile range [IQR], 24-52) weeks in the aflibercept group vs 4 (IQR, 4-4) weeks in the vitrectomy group (difference, 32 [95% CI, 20-32] weeks; P < .001). Conclusions and Relevance Both initial aflibercept and vitrectomy with PRP are viable treatment approaches for PDR-related vitreous hemorrhage. Although this study did not find a significant difference between groups in the primary outcome of mean VA over 24 weeks of follow-up, eyes receiving initial vitrectomy with PRP had faster recovery of vision over 24 weeks when baseline VA was worse than 20/800 and faster vitreous hemorrhage clearance. Approximately one-third of the eyes in each group received the alternative treatment (aflibercept or vitrectomy with PRP). These factors may influence treatment decisions for patients initiating therapy for PDR-related vitreous hemorrhage.Questions Among eyes with vitreous hemorrhage due to proliferative diabetic retinopathy initially treated with aflibercept or vitrectomy with panretinal photocoagulation, what changes occur in visual acuity and other ocular outcomes? Findings In this comparative effectiveness study of 205 eyes undergoing treatment, no difference in mean visual acuity over 24 weeks was noted between treatment groups. Results of post hoc analyses show that the vitrectomy group had better visual acuity over 24 weeks of follow-up in the subgroup of eyes with baseline best-corrected visual acuity worse than 20/800. Meaning Aflibercept and vitrectomy are viable treatment options for vitreous hemorrhage due to proliferative diabetic retinopathy, and the results of this study may influence treatment decisions when initiating therapy.