Effect of Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation on Visual Acuity in Patients With Vitreous Hemorrhage From Proliferative Diabetic Retinopathy: A Randomized Clinical Trial

Key PointsQuestionAmong patients with vitreous hemorrhage from proliferative diabetic retinopathy, what is the effect of initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation on vision? FindingsIn this randomized trial of 205 eyes among 205 participants, the mean visual acuity letter score over 24 weeks was 59.3 (Snellen equivalent, 20/63) for the aflibercept group vs 63.0 (Snellen equivalent, 20/63) for the vitrectomy with panretinal photocoagulation group, a difference that was not statistically significant. MeaningIn participants with vitreous hemorrhage from proliferative diabetic retinopathy, there was no statistically significant difference in visual acuity over 24 weeks following initial treatment with aflibercept vs vitrectomy with panretinal photocoagulation, but the study may have been underpowered to detect a clinically important benefit in favor of initial vitrectomy with panretinal photocoagulation. ImportanceVitreous hemorrhage from proliferative diabetic retinopathy can cause loss of vision. The best management approach is unknown. ObjectiveTo compare initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation for vitreous hemorrhage from proliferative diabetic retinopathy. Design, Setting, and ParticipantsRandomized clinical trial at 39 DRCR Retina Network sites in the US and Canada including 205 adults with vison loss due to vitreous hemorrhage from proliferative diabetic retinopathy who were enrolled from November 2016 to December 2017. The final follow-up visit was completed in January 2020. InterventionsRandom assignment of eyes (1 per participant) to aflibercept (100 participants) or vitrectomy with panretinal photocoagulation (105 participants). Participants whose eyes were assigned to aflibercept initially received 4 monthly injections. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol criteria. Main Outcomes and MeasuresThe primary outcome was mean visual acuity letter score (range, 0-100; higher scores indicate better vision) over 24 weeks (area under the curve); the study was powered to detect a difference of 8 letters. Secondary outcomes included mean visual acuity at 4 weeks and 2 years. ResultsAmong 205 participants (205 eyes) who were randomized (mean [SD] age, 57 [11] years; 115 [56%] men; mean visual acuity letter score, 34.5 [Snellen equivalent, 20/200]), 95% (195 of 205) completed the 24-week visit and 90% (177 of 196, excluding 9 deaths) completed the 2-year visit. The mean visual acuity letter score over 24 weeks was 59.3 (Snellen equivalent, 20/63) (95% CI, 54.9 to 63.7) in the aflibercept group vs 63.0 (Snellen equivalent, 20/63) (95% CI, 58.6 to 67.3) in the vitrectomy group (adjusted difference, -5.0 [95% CI, -10.2 to 0.3], P=.06). Among 23 secondary outcomes, 15 showed no significant difference. The mean visual acuity letter score was 52.6 (Snellen equivalent, 20/100) in the aflibercept group vs 62.3 (Snellen equivalent, 20/63) in the vitrectomy group at 4 weeks (adjusted difference, -11.2 [95% CI, -18.5 to -3.9], P=.003) and 73.7 (Snellen equivalent, 20/40) vs 71.0 (Snellen equivalent, 20/40) at 2 years (adjusted difference, 2.7 [95% CI, -3.1 to 8.4], P=.36). Over 2 years, 33 eyes (33%) assigned to aflibercept received vitrectomy and 34 eyes (32%) assigned to vitrectomy received subsequent aflibercept. Conclusions and RelevanceAmong participants whose eyes had vitreous hemorrhage from proliferative diabetic retinopathy, there was no statistically significant difference in the primary outcome of mean visual acuity letter score over 24 weeks following initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation. However, the study may have been underpowered, considering the range of the 95% CI, to detect a clinically important benefit in favor of initial vitrectomy with panretinal photocoagulation. Trial RegistrationClinicalTrials.gov Identifier: NCT02858076 This randomized trial compares the effects of initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation on visual acuity over 24 weeks among adults with vitreous hemorrhage from proliferative diabetic retinopathy.