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A. C. Ho, S. Gray, A. Rundle, Z. Li, W. Yee Murahashi, R. Rubio, for the BRAVO and CRUISE Investigators; Ranibizumab in Patients With Macular Edema Following Retinal Vein Occlusion: 12-Month Outcomes of BRAVO and CRUISE. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6452.
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Report 12-month outcomes of BRAVO and CRUISE.
During the treatment period (Day 0-Month 5), patients with macular edema (ME) following branch (BRAVO; n=397) or central (CRUISE; n=392) retinal vein occlusion (RVO) received monthly intraocular injections of 0.3 mg or 0.5 mg ranibizumab or sham injections. During the observation period (Months 6-11) all patients could receive monthly ranibizumab if they met prespecified criteria: Snellen equivalent study eye best-corrected visual acuity (BCVA) 20/40 or worse or mean central subfield thickness ≥250 µm; 0.3 mg and 0.5 mg groups received their assigned dose; sham group received 0.5 mg ranibizumab. The primary efficacy endpoint was mean change from baseline BCVA letter score at Month 6. Secondary endpoints at Month 12 included mean change from baseline BCVA letter score and mean change from baseline central foveal thickness (CFT) over time.
In BRAVO and CRUISE, mean changes from baseline BCVA and CFT at Month 6 were significantly greater for patients who received ranibizumab compared with sham injections (Table). The improvements relative to baseline were maintained with PRN treatment to Month 12. Sham patients who received 0.5 mg ranibizumab PRN during the observation period had gained comparatively fewer letters at Month 12. Incidence of AEs to Month 12 was low in all groups.
Functional and anatomical efficacy outcomes of monthly ranibizumab in patients with ME following RVO were maintained during 6 months of PRN treatment. PRN treatment in sham patients resulted in comparatively less BCVA gain at Month 12. Safety outcomes at Month 12 were consistent with those at Month 6.
www.clinicaltrials.gov NCT00486018 / NCT00485836
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