Ranibizumab for Macular Edema following Central Retinal Vein Occlusion: Six-Month Primary End Point Results of a Phase III Study
Portions of these data were presented at: the Retina Congress, September 2009, New York, NY; and the American Academy of Ophthalmology, November 2009, San Francisco, CA.
Received 24 December 2009; received in revised form 11 February 2010; accepted 17 February 2010. published online 09 April 2010.
Purpose
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).
A total of 392 patients with macular edema after CRVO.
Methods
Eligible patients were randomized 1:1:1 to receive monthly intraocular injections of 0.3 or 0.5 mg of ranibizumab or sham injections.
Main Outcome Measures
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).
Results
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 ≥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 ≥ 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 μm (0.3 mg) and 452 μm (0.5 mg) in the ranibizumab groups and 168 μm 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.
Conclusions
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.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found after the references.
Available online: April 9, 2010.
1Retina Consultants of Houston, The Methodist Hospital, Houston, Texas
2Johns Hopkins University School of Medicine, Baltimore, Maryland
3Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio
This article contains online-only material. The following should appear online only: CRUISE Investigators (see Appendix 1; available at http://aaojournal.org).
Financial Disclosure(s): The author(s) have made the following disclosure(s): Genentech, Inc., South San Francisco, California, provided support for the study and participated in study design; conducting the study; and data collection, management, and interpretation. Genentech authors Saroj, Rundle, and Gray would like to report Equity Ownership in Roche.
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