Table 3.
Study design and key efficacy data for RCTs investigating CRVO or CRVO and BRVO (efficacy data are presented at 6 months unless otherwise indicated)
| Study design and patient characteristics | CRUISE [[42]] | ROCC [[44]] | Pooled data from both GENEVA trials [[18]] | CVOS group [[10]] (data presented at 12 months) | Laatikainen et al [[46]] (data presented at 12 months) | May et al [[47]] (data presented at 24 months) | Faghihi et al [[48]] | Kuppermann et al [[20]] (BRVO and CRVO – data presented at 3 months) |
|---|---|---|---|---|---|---|---|---|
| Study design |
Blinded RCT |
Blinded RCT |
Blinded RCT |
Blinded RCT |
RCT (blinding not reported) |
RCT (blinding not reported) |
Blinded RCT |
Blinded RCT |
| Study qualitya |
6/8 |
4/8 |
7/8 |
5/8 |
5/8 |
5/8 |
Poster only |
7/8 |
| Treatment arms |
1. RBZ 0.3 mg |
1. RBZ 0.5 mg |
1. Dex IVT 0.7 mg |
1. Laser |
1. Laser |
1. Laser |
1. IVB |
1. Dex IVT |
| 2. RBZ 0.5 mg |
2. Sham |
2. Dex IVT 0.35 mg |
2. No treatment |
2. No treatment |
2. No treatment |
2. Sham |
0.7 mg/ |
|
| 3. Sham (laser) |
|
3. Sham |
|
|
|
|
0.35 mg |
|
| 2. No treatment | ||||||||
| Key inclusion/exclusion criteria |
Age ≥ 18 years ETDRS: 20/50–20/320 Mean CST: ≥ 250 μm |
Age ≥ 50 years ETDRS: 6–73 letters |
Age ≥ 18 years BCVA < 20/50 |
VA 20/50–5/200 |
VA ≤ 6/24 |
Age > 40 years VA < 20/40 |
BCVA ≤ 20/50 |
Persistent macular oedema following laser |
| No. eyes (patients) randomized per arm |
1. 132 |
1. 15 |
1. 136 |
1. 68 |
1. 24 |
1. 15 |
NR |
1. 35 |
| 2. 130 |
2. 14 |
2. 154 |
2. 72 |
2. 24 |
2. 19 |
|
2. 34 |
|
| 3. 130 |
|
3. 147 |
|
|
|
|
|
|
| Study duration |
6 months |
6 months |
6 months |
36 months |
12 months |
28.5 months |
NR |
6 months |
| Efficacy |
|
|
|
|
|
|
|
|
| Mean change in BCVA, mean (SD) |
1. 12.7 (15.9)* |
1. 12 (20.0)* |
1. 0.1b |
NR |
NR |
NR |
NR |
NR |
| 2. 14.9 (13.2)* |
2. 1 (17.0) |
2. NR |
||||||
| 3. 0.8 (16.2) |
|
3. −1.8b |
||||||
| Number of patients gaining ≥ 15 letters (%) |
1. 61 (46.2)* |
NR |
1. 24 (17.6) |
NR |
NR |
NR |
NR |
NR |
| 2. 62 (47.7)* |
|
2. 26 (16.9) |
||||||
| 3. 22 (16.9) |
|
3. 18 (12.2) |
||||||
| Number of patients gaining ≥ 10 letters (%) | 1. 82 (62.1)* |
NR |
1. 36 (26.5) |
1. 10 (14.7) |
1. 2 (8.3) |
1. 3 (20.0) |
NR |
1. 31 (88.6)* |
| 2. 92 (70.8)* |
|
2. NR |
2. 6 (8.3) | 2. 2 (8.3) | 2. 5 (26.3) | 2. 15 (44.1) | ||
| 3. 33 (25.4) | 3. 35 (23.8) |
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; BRVO, Branch retinal vein occlusion; CMT, Central macular thickness; CRUISE, Ranibizumab for the Treatment of Macular Edema after Central Retinal Vein OcclUsIon Study: Evaluation of Efficacy and Safety; CVOS, Central Retinal Vein Occlusion Study; CRVO, Central retinal vein occlusion; 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; RBZ, Ranibizumab; RCT, randomized controlled trial; ROCC, Study Comparing Ranibizumab to Sham in Patients with Macular Edema Secondary to Central Retinal vein OCClusion; VA, Visual acuity; NR, Not reported; SD, standard deviation.