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Original Investigation
December 15, 2020

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

Author Affiliations
  • 1Charlotte Eye, Ear, Nose & Throat Associates, Charlotte, North Carolina
  • 2Jaeb Center for Health Research, Tampa, Florida
  • 3Feinberg School of Medicine, Northwestern University, Chicago, Illinois
  • 4Retina Research Center, Austin, Texas
  • 5Dell Medical School, University of Texas, Austin
  • 6Retina Associates of Southern California, Huntington Beach
  • 7Palmetto Retina Center, Columbia, South Carolina
  • 8Department of Ophthalmology, University of Pennsylvania, Philadelphia
  • 9Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio
  • 10Joslin Diabetes Center, Beetham Eye Institute, Department of Ophthalmology, Harvard University, Boston, Massachusetts
JAMA. 2020;324(23):2383-2395. doi:10.1001/jama.2020.23027
Visual Abstract. Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation for Vitreous Hemorrhage
Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation for Vitreous Hemorrhage
Key Points

Question  Among 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?

Findings  In 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.

Meaning  In 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.

Abstract

Importance  Vitreous hemorrhage from proliferative diabetic retinopathy can cause loss of vision. The best management approach is unknown.

Objective  To compare initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation for vitreous hemorrhage from proliferative diabetic retinopathy.

Design, Setting, and Participants  Randomized 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.

Interventions  Random 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 Measures  The 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.

Results  Among 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 Relevance  Among 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 Registration  ClinicalTrials.gov Identifier: NCT02858076

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