Baseline characteristics and results of all included studies
| Study | Participants | Intervention/outcomes |
|---|---|---|
| DEXAMETHASONE | ||
| GENEVA 20106–8 International Setting: multicentre (167 centres in 24 countries, so a mean of 2.6 patients per centre) Design: 2 identical double-blind, sham-controlled RCTs, phase 3 Follow-up: primary endpoint for the masked trial: 6 months; primary endpoint for the open-label extension: 12 months | N: CRVO—437 eyes of 437 patients randomised; 94% follow-up at 6 months Participants: adults with visual acuity reduced because of macular oedema due to CRVO or BRVO | 1. Dexamethasone 0.7 mg (n=136) Single dose 2. Dexamethasone 0.35 mg (n=154) Single dose 3. Sham (n=147) Single dose—a needleless applicator was placed against the conjunctiva to simulate the placement of study medication. Primary end point: gain of ≥15 ETDRS letters; for the open-label extension: safety |
| TRIAMCINOLONE | ||
| SCORE 200923–36 USA Setting: multicentre Design: RCT Follow-up: primary end point 12 months, FU planned up to 36 months | N: 271 eyes of 271 patients randomised; 83% (observation) and 90% (triamcinolone) completed 12 months Participants: centre-involved macular oedema secondary to CRVO | 1. Triamcinolone 1 mg (n=92) Every 4 months depending on retreatment regimen (average 2.2 injections at 12 months) 2. Triamcinolone 4 mg (n=91) Every 4 months depending on retreatment regimen (average 2.0 injections at 12 months) (The form of triamcinolone used was Trivaris, no longer available. It was made by the manufacturer of Ozurdex (Allergan)) 3. Observation (n=88) Primary end point: gain of ≥15 ETDRS letters |
| AFLIBERCEPT | ||
| COPERNICUS 201212 13 International Setting: multicentre, 70 sites in North and South America, India and Israel. Mean 2.7 patients per centre Design: double-blind, sham-controlled RCT, phase 3 Follow-up: primary end point 24 weeks, FU 2 years | N: 189 eyes of 189 patients randomised; 95.7% (aflibercept) and 81.1% (sham) completed 24 weeks; 93% (aflibercept) and 77% (sham) completed 52 weeks Participants: adult patients with centre-involved CRVO for a maximum of 9 months | 1. Aflibercept 2 mg (n=114) Every 4 weeks for 6 months (average number not available) 2. Sham (n=73) Every 4 weeks for 6 months (average number not available) (empty syringe without needle pressed to conjunctival surface) Primary end point: gain of ≥15 ETDRS letters |
| GALILEO 201211 International Setting: multicentre, 10 countries in Europe and Asia; 63 centres in total Design: double-blind, sham-controlled RCT, phase 3 Follow-up: primary end point 24 weeks, FU up to 12 months, planned up to 76 weeks | N: 177 eyes of 177 patients randomised; 90.6% (aflibercept) and 78.9% (sham) completed 24 weeks Participants: treatment-naïve patients with centre-involved CRVO for a maximum of 9 months | 1. Aflibercept 2 mg (n=103) Every 4 weeks for 6 months (average number not available) 2. Sham (n=71) Every 4 weeks for 6 months (average number not available) (empty syringe without needle pressed to conjunctival surface) Primary end point: gain of ≥15 ETDRS letters |
| RANIBIZUMAB | ||
| CRUISE 20109 10 USA Setting: multicentre Design: double-blind, sham-controlled RCT, phase 3 Follow-up: primary end point 6 months, FU up to 12 months | N: 392 eyes of 392 patients randomised; 97.7% (ranibizumab 0.3 mg), 91.5% (ranibizumab 0.5 mg) and 88.5% (sham) completed 6 months Participants: patients with foveal centre-involved macular oedema secondary to CRVO diagnosed within 12 months | 1. Ranibizumab 0.3 mg (n=132) Every 4 weeks for 6 months (average number not available) 2. Ranibizumab 0.5 mg (n=130) Every 4 weeks for 6 months (average number not available) 3. Sham (n=130) Every 4 weeks for 6 months (average number not available) (empty syringe without needle pressed to the injection site) Primary end point: mean change from baseline BCVA |
| BEVACIZUMAB | ||
| EPSTEIN 201242–44 Sweden Setting: Single centre; St. Eriks Eye Hospital Stockholm Design: sham-injection controlled, double maskedRCT Follow-up: primary endpoint 6 months; open label extension up to 12 months | N: 60 eyes of 60 patients randomised; 93% completed open label extension Participants: patients with CRVO of ≤6 months | 1. Bevacizumab 1.25 mg (n=30) Every 6 weeks for 6 months (average number not available) 2. Sham (n=30) Every 6 weeks for 6 months (averege number not available) (syringe without needle pressed to the globe) Primary end point: gain of ≥15 ETDRS letters |
BCVA, best corrected visual acuity; BRVO, branch retinal vein occlusion; CRVO, central retinal vein occlusion; ETDRS, Early Treatment Diabetic Retinopathy Study; FU, follow-up; N, number; RCT, randomised controlled trial.