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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)

From: Efficacy and safety of widely used treatments for macular oedema secondary to retinal vein occlusion: a systematic review

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)

  1. 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.
  2. bData taken from manufacturer’s submission to NICE [32] (standard deviations were not reported).
  3. *Statistically significant compared with sham/no treatment.
  4. 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.
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BMC Ophthalmology

ISSN: 1471-2415

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