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

Table 5 Incidence of ocular AEs following treatment with ranibizumab [[42][43]] and dex IVT [[18][32]] at 6 months

	BRAVO [[43]]^a		CRUISE [[42]]^a		GENEVA^b(BRVO and CRVO combined) [[18],[32]]
Adverse event	0.5 mg	Sham	0.5 mg	Sham	0.7 mg	Sham
Adverse event	N = 130	N = 131	N = 129	N = 129	N = 421	N = 423
Increased intraocular pressure^c, N (%)	7 (5.4)	2 (1.5)	11 (8.5)	4 (3.1)	106 (25.2)^d OR 28.54, 95% CI 11.48, 70.95	5 (1.2)^d
Ocular hypertension, N (%)	NR	NR	NR	NR	17 (4.0) P = 0.002	3 (0.7)
Eye pain, N (%)	21 (16.2)	19 (14.5)	24 (18.6)	13 (10.1)	31 (7.4)	16 (3.8)
Cataract, N (%)	4 (3.1)	4 (3.1)	2 (1.6)	0	31 (7.3)	19 (4.5)
Endophthalmitis, N (%)	1 (0.8)	0	0	0	NR	NR
Retinal detachment, N (%)	0	0	0	0	1	1
Iris neovascularization, N (%)	0	3 (2.3)	1 (0.8)	9 (7.0)	0	6 (1.4)
Retinal neovascularization, N (%)	0	5 (3.8)	2 (1.6)	3 (2.3)	3 (0.7) P = 0.032	11 (2.6)
Neovascular glaucoma, N (%)	0	0	0	2 (1.6)	NR	NR
Retinal tear, N (%)	0	0	0	0	NR	NR
Vitreous haemorrhage, N (%)	2 (1.5)	6 (4.6)	7 (5.4)	9 (7.0)	10 (2.4)	12 (2.8)
Retinal haemorrhage, N (%)	19 (14.6)	16 (12.2)	10 (7.8)	13 (10.0)	12 (2.9)	10 (2.4)

^aKey study eye AEs through month 6.
^bOcular AEs in the study eye reported by > 2% of patients in any treatment group.
^cDefined as ≥ 30 mmHg in BRAVO and CRUISE, and ≥ 25 mmHg in GENEVA.
^dData from the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE).
AE, adverse event; BRAVO, Ranibizumab for the Treatment of Macular Edema after BRAnch retinal Vein Occlusion: Evaluation of Efficacy and Safety; BRVO, Branch retinal vein occlusion; CRUISE, Ranibizumab for the Treatment of Macular Edema after Central Retinal Vein OcclUsIon Study: Evaluation of Efficacy and Safety; CRVO, Central retinal vein occlusion; dex IVT, Dexamethasone intravitreal; GENEVA, Global EvaluatioN of implantable dExamethasone in retinal Vein occlusion with macular edemA; NR, Not reported.

ISSN: 1471-2415