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

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 quality^a	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	BCVA < 20/50			CMT ≥ 30 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. 7.4^b*	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. 4.9^b			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)
≥ 15 letters (%)	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)
≥ 10 letters (%)	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.

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