Table 1.
Select clinical trials evaluating intravitreal pharmacotherapy for branch retinal vein occlusion associated macular edema
| Studya | Treatment | Subjects | Duration | Mean number of injections | Mean letter change in BCVAa | % of eyes gaining ≥15 letters |
|---|---|---|---|---|---|---|
| SCORE-BRVO6 | Triamcinolone (1 mg) | 136 | 12 months | 2.2 (95% CI, 2.1–2.4) | +5.7 (95% CI, 2.8–8.6) | 26% |
| Triamcinolone (4 mg) | 137 | 2.1 (95% CI, 2.0–2.3) | +4 (95% CI, 0.9–7.2) | 27% | ||
| Grid-pattern laser | 137 | N/A | +4.2 (95% CI, 1.1–7.3) | 29% | ||
| GENEVA-BRVO18 | Dexamethasone implant (0.35 mg) | 373b | 6 months followed by 6-month open-label extension | 1.85 | 21% (6 months) | |
| Dexamethasone implant (0.7 mg) | 383b | 1.86 | ~+6 | 23% (6 months) | ||
| Sham/0.7 mg | 375b | 0.83 | ~+6 | 20% (6 months) | ||
| BRAVO27 | Ranibizumab (0.3 mg) | 134 | 6 months followed by 6-month open-label extension | 8.3 | +16.4 (95% CI, 14.5–18.4) | 56% |
| Ranibizumab (0.5 mg) | 131 | 8.4 | +18.3 (95% CI, 15.8–20.9) | 60.3% | ||
| Sham/0.5 mg | 132 | 5.7 | +12.1 (95% CI, 9.6–14.6) | 43.9% | ||
| HORIZON-BRVO29 | Ranibizumab (0.3/0.5 mg) | 103 | 12-month open-label extension of BRAVO trial | 2.4 | +14.9 | 50% |
| Ranibizumab (0.5/0.5 mg) | 104 | 2.1 | +17.5 | 60.3% | ||
| Sham/0.5 mg | 97 | 2 | +15.6 | 51.5% | ||
| RETAIN-BRVO30 | Ranibizumab (0.5 mg) | 34 | 49-month open-label extension of BRAVO trial | 2.6 (year 2), 2.1 (year 3), and 2.0 (year 4) | +20.1 | 62% |
| SHORE-BRVO31 | Ranibizumab (0.5 mg PRN) | 50 | 15 months | 3.8 (SD, 2.0) | +21.0 (SD, 14.1) | 70.7% (both CRVO and BRVO) |
| Ranibizumab (0.5 mg monthly) | 48 | 7.6 (SD, 1.0) | +18.7 (SD, 14.1) | 66.3% (both CRVO and BRVO) | ||
| RELATE-BRVO43 | Ranibizumab (0.5 mg) | 22 | 24 weeks, 144 weeks for second randomization | N/A | +12.1 | 27.3% |
| Ranibizumab (2.0 mg) | 20 | N/A | 14.6 | 50.0% | ||
| Second randomization after 24 weeks: ranibizumab alone versus ranibizumab + sector laser | 42 | Comment: No significant differences in visual outcome or mean number of injections between ranibizumab alone versus ranibizumab + sector laser at week 144 | ||||
| VIBRANT11 | Aflibercept (2 mg) | 91 | 6 months | 5.7 | +17.0 | 52.7% |
| Grid-pattern laser | 92 | N/A | +6.9 | 26.7% | ||
| MARVEL33 | Bevacizumab (1.25 mg) | 38 | 6 months | 3.0 (SD, 1.4) | +15.6 (95% CI, 12.0–20.5) | 57.8% |
| Ranibizumab (0.5 mg) | 37 | 3.2 (SD, 1.5) | +18.1 (95% CI, 12.8–226) | 59.4% | ||
Notes:
Outcomes are not directly comparable because study populations varied due to different entry criteria and individual study duration.
Subjects for both BRVO and CRVO. Exact BRVO numbers are not reported, but it is stated that approximately half of the patients had BRVO.
Abbreviations: BCVA, best-corrected visual acuity; BRVO, branch retinal vein occlusion; N/A, not available; 95% CI, 95% confidence interval; CRVO, central retinal vein occlusion; SD, standard deviation; PRN, pro-re-nata; SCORE, the Standard Care versus Corticosteroid for Retinal Vein Occlusion trial; GENEVA, sham-controlled randomized trial of Dexamethasone Intravitreal Implant in Patients with Macular Edema due to Retinal Vein Occlusion; BRAVO, the Ranibizumab for the Treatment of Macular Edema following BRAnch Retinal Vein Occlusion: Evaluation of Efficacy and Safety trial; HORIZON, Open-Label Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects with Choroidal Neovascularization Secondary to Age-related Macular Degeneration or Macular Edema Secondary to Retinal Vein Occlusion trial; RETAIN, BRanch RETinal Vein Occlusion or CentrAl Retinal VeIn OcclusioN Previously Treated with Intravitreal Ranibizumab; SHORE, Study Evaluating Dosing Regimens for Treatment with Intravitreal Ranibizumab Injections in Subjects with Macular Edema following Retinal Vein Occlusion Trial; RELATE, the Ranibizumab Dose Comparison (0.5 mg and 2.0 mg) and the Role of Laser in the Management of Retinal Vein Occlusion trial; VIBRANT, study to evaluate intravitreal aflibercept for BRVO; MARVEL, MAcular edema due to branch Retinal VEin OccLusion trial.