To assess the efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab
in patients with macular edema after central retinal vein occlusion (CRVO).
Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical
A total of 392 patients with macular edema after CRVO.
Eligible patients were randomized 1:1:1 to receive monthly intraocular injections
of 0.3 or 0.5 mg of ranibizumab or sham injections.
The primary efficacy outcome measure was mean change from baseline best-corrected
visual acuity (BCVA) letter score at month 6. Secondary outcomes included other parameters
of visual function and central foveal thickness (CFT).
Mean (95% confidence interval [CI]) change from baseline BCVA letter score at month
6 was 12.7 (9.9-15.4) and 14.9 (12.6-17.2) in the 0.3 mg and 0.5 mg ranibizumab groups,
respectively, and 0.8 (-2.0 to 3.6) in the sham group (P<0.0001 for each ranibizumab
group vs. sham). The percentage of patients who gained > or =15 letters in BCVA at
month 6 was 46.2% (0.3 mg) and 47.7% (0.5 mg) in the ranibizumab groups and 16.9%
in the sham group (P<0.0001 for each ranibizumab group vs. sham). At month 6, significantly
more ranibizumab-treated patients (0.3 mg = 43.9%; 0.5 mg = 46.9%) had BCVA of > or
= 20/40 compared with sham patients (20.8%; P<0.0001 for each ranibizumab group vs.
sham), and CFT had decreased by a mean of 434 microm (0.3 mg) and 452 microm (0.5
mg) in the ranibizumab groups and 168 microm in the sham group (P<0.0001 for each
ranibizumab group vs. sham). The median percent reduction in excess foveal thickness
at month 6 was 94.0% and 97.3% in the 0.3 mg and 0.5 mg groups, respectively, and
23.9% in the sham group. The safety profile was consistent with previous phase III
ranibizumab trials, and no new safety events were identified in patients with CRVO.
Intraocular injections of 0.3 mg or 0.5 mg ranibizumab provided rapid improvement
in 6-month visual acuity and macular edema following CRVO, with low rates of ocular
and nonocular safety events.
Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights