Table 2.
Study design and key efficacy data for RCTs investigating treatments for BRVO (efficacy data are presented at 6 months unless otherwise indicated)
| Study design and patient characteristics | BRAVO [[43]] | Pooled data from both GENEVA trials [[18]] | Battaglia Parodi et al [[45]] (data presented at 9 months) | BVOS group [[6]] (data presented at 36 months) | Russo et al [[50]] | Moradian et al [[49]] (data presented at 6 weeks) |
|---|---|---|---|---|---|---|
| Study design |
Blinded RCT |
Blinded RCT |
RCT (blinding not reported) |
Blinded RCT |
Unblinded RCT |
Blinded RCT |
| Study qualitya |
6/8 |
7/8 |
3/8 |
7/8 |
5/8 |
7/8 |
| Treatment arms |
1. RBZ 0.3 mg |
1. Dex IVT 0.7 mg |
1. Laser |
1. Laser |
1. Laser |
1. IVB |
| 2. RBZ 0.5 mg |
2. Dex IVT 0.35 mg |
2. No treatment |
2. No treatment |
2. IVB |
2. Sham |
|
| 3. Sham (laser) |
3. Sham |
|
|
|
|
|
| Key inclusion/exclusion criteria |
Age ≥ 18 years |
Age ≥ 18 years |
VA < 0.6 |
VA ≤ 20/40 |
logMAR ETDRS ≤ 0.4 |
BCVA ≤ 20/50 |
| ETDRS BCVA: 20/50–20/400 |
BCVA < 20/50 |
|
|
CMT ≥ 30 μm |
|
|
| Mean CST ≥ 250 μm | ||||||
| No. eyes (patients) randomized per arm |
1. 134 |
1. 291 |
1. 33 |
1. 43 |
1. 15 |
1. 42 |
| 2. 131 |
2. 260 |
2. 35 |
2. 35 |
2. 15 |
2. 39 |
|
| 3. 132 |
3. 279 |
|
|
|
|
|
| Study duration |
6 months |
6 months |
24 months |
36 months |
12 months |
3 months |
| Efficacy |
|
|
|
|
|
|
| Mean change in BCVA, mean (SD) |
1. 16.6 (11.0)* |
1. 7.4b* |
1. 0.7 (0.2) |
NR |
1. 0.68 (0.13) |
1. 0.49 (0.32)* |
| 2. 18.3 (13.2)* |
2. NR |
2. 0.7 (0.2) |
|
2. 0.57 (0.16) |
2. 0.75 (0.48) |
|
| 3. 7.3 (13.0) |
3. 4.9b |
|
|
logMAR |
|
|
| Number of patients gaining |
1. 74 (55.2)* |
1. 67 (23.0) |
NR |
NR |
1. 7 (46.7) |
NR |
| ≥ 15 letters (%) |
2. 80 (61.1)* |
2. NR |
|
|
2. 11 (73.3) |
|
| 3. 38 (28.8) |
3. 56 (20.1) |
|
|
|
|
|
| Number of patients gaining |
1. 99 (73.9)* |
1. 120 (41.2)* |
NR |
1. 28 (65.1)* |
NR |
NR |
| ≥ 10 letters (%) | 2. 103 (78.6)* |
2. 55 (21.2) |
|
2. 13 (37.1) |
|
|
| 3. 53 (40.2) | 3. 92 (33.0) |
aStudy quality was judged on the following criteria: randomization, allocation, blinding, similarity of groups, loss to follow-up, imbalance between groups, reporting of data from intention-to-treat group and whether the study was free of selective reporting. Detailed assessment of study quality is presented in Additional file 2.
bData taken from manufacturer’s submission to NICE [32] (standard deviations were not reported).
*Statistically significant compared with sham/no treatment.
BCVA, Best-corrected visual acuity; BRAVO, Ranibizumab for the Treatment of Macular Edema after BRAnch retinal Vein Occlusion: Evaluation of Efficacy and Safety; BRVO, Branch retinal vein occlusion; BVOS, Branch Retinal Vein Occlusion Study; CMT, Central macular thickness; CST, Central subfield thickness; Dex IVT, Dexamethasone intravitreal; ETDRS, Early Treatment Diabetic Retinopathy Study; GENEVA, Global EvaluatioN of implantable dExamethasone in retinal Vein occlusion with macular edemA; IVB, Intravitreal bevacizumab; logMAR, Logarithm of minimum angle of resolution; RBZ, Ranibizumab; RCT, Randomized controlled trial; VA, Visual acuity; NR, Not reported; SD, standard deviation.