Race and Vision Outcomes in Ranibizumab-Treated Participants With Diabetic Macular Edema

Abstract

ImportanceVision outcomes in response to anti–vascular endothelial growth factor therapy for diabetic macular edema (DME) may differ between races. This meta-analysis investigated whether vision outcomes differed among racial subgroups treated with ranibizumab for DME in a clinical trial setting.ObjectiveTo assess the impact of race on vision outcomes in participants with DME treated with ranibizumab.Data SourcesFive randomized clinical trials were preselected for analysis, including the RIDE and RISE trials (Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus); Protocol I (Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination With Laser Photocoagulation for Diabetic Macular Edema), Protocol S (Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab With Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy), and Protocol T (A Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab and Ranibizumab for Diabetic Macular Edema).Study SelectionTargeted meta-analysis of data from 5 trials.Data Extraction and SynthesisTotal enrollment numbers allowed for comparison of Black and White participants with DME who were treated with ranibizumab (0.3 mg or 0.5 mg) and had best-corrected visual acuity (BCVA) data at baseline and month 24. Lower total enrollment of participants of other races precluded statistical analysis. All ranibizumab-treated arms were pooled. Differences in vision outcomes between Black and White participants were evaluated, adjusting for baseline vision. Propensity score–matched models for participants in RIDE/RISE were used to control for differences in baseline and on-study characteristics.Main Outcomes and MeasuresMean BCVA over time and mean change from baseline at month 24 by race (Black and White).ResultsAmong the 1109 participants, the mean age was 60.0 years (95% CI, 59.4-60.7); 621 participants were male and 488 were female; 181 participants were Black and 928 were White. BCVA was better at baseline in Black vs White participants (mean Early Treatment Diabetic Retinopathy Study [ETDRS] letter score, 66.7 [95% CI, 65.0-68.4] vs 62.0 [95% CI, 61.1-62.8], respectively) but similar at month 24 (mean ETDRS letter score, 72.8 [95% CI, 70.2-75.4] vs 72.2 [95% CI, 71.2-73.1]). Mean BCVA change from baseline at month 24 was lower in Black vs White participants (6.1 ETDRS letters [95% CI, 3.6-8.6] vs 10.2 ETDRS letters [95% CI, 9.3-11.1]) and after adjusting for differences in baseline BCVA (7.7 ETDRS letters [95% CI, 5.8-9.7] vs 9.9 ETDRS letters [95% CI, 9.0-10.7]). When groups were propensity score–matched in RIDE/RISE, mean BCVA change from baseline appeared similar between Black vs White participants (10.6 ETDRS letters [95% CI, 7.1-14.1] vs 10.1 ETDRS letters [95% CI, 7.3-12.9]; P = .83).Conclusions and RelevanceThis meta-analysis evaluating ranibizumab for DME found that baseline BCVA was better in Black vs White participants, and BCVA change from baseline at month 24 was smaller in Black vs White participants. No difference in BCVA was observed in Black vs White participants at 2 years. Smaller enrollment numbers precluded analysis of participants of other races, suggesting lack of robust diversity beyond Black and White participants in these trials.