Original articleSustained Benefits from Ranibizumab for Macular Edema following Central Retinal Vein Occlusion: Twelve-Month Outcomes of a Phase III Study
Section snippets
Study Design
The CRUISE Study was a 12-month, phase III, multicenter, randomized trial that included a 6-month, injection-controlled treatment period followed by a 6-month observation period, designed to evaluate efficacy and safety of intraocular injections of ranibizumab in patients with macular edema following CRVO. Details of the CRUISE methodology were previously reported7 and are briefly summarized here. During the treatment period (day 0–month 5) patients received monthly intraocular injections of
Patient Characteristics and Disposition
We randomized 392 patients to receive intraocular injections of 0.3 mg ranibizumab (n = 132) or 0.5 mg ranibizumab (n = 130) or sham injections (n = 130) at 95 centers in the United States. Patient demographics and baseline ocular characteristics were similar across treatment groups. The mean time from diagnosis of CRVO to screening was 3.3 months (median 2 months for each treatment group), with a duration of ≤3 months in 69% of patients. Mean baseline BCVA letter score was 48.3 letters
Discussion
Monthly intraocular injections of 0.3 mg or 0.5 mg of ranibizumab for 6 months provided substantial benefit in patients with CRVO, resulting in mean improvements from baseline BCVA letter score of 12.7 and 14.9. This benefit was maintained during the subsequent 6 months in which injections were given only if retreatment criteria were met, so that at 12 months, the mean improvement in BCVA letter score was 13.9 in each ranibizumab treatment group. This indicates that after a period of aggressive
Acknowledgments
The authors thank Roberta Kelly of Genentech, Inc., for editing, formatting, and preparation of figures.
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Manuscript no. 2010-1755.
Financial Disclosure(s): Financial disclosure/conflict of interest: 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.
Peter A. Campochiaro – Alcon – Financial Support; Alimera – Financial Support; Genentech – Financial Support, Consultant; Bristol-Myers Squibb (past) – Consultant; Genzyme – Financial Support; LPath – Consultant; Regeneron – Consultant; Molecular Partners – Financial Support; GlaxoSmithKline – Financial Support, Consultant; Oxford Biomedical – Financial Support; Pfizer – Consultant.
David M. Brown – Alcon – Consultant, Financial Support; Alimera – Consultant, Financial Support; Allergan – Consultant, Financial Support; Eli Lilly – Financial Support; Genentech – Consultant, Lecturer, Financial Support; Heidelberg – Consultant, Financial Support; Molecular Partners – Consultant, Financial Support; Novartis – Consultant, Lecturer, Financial Support; Paloma – Consultant, Financial Support; Regeneron – Consultant, Financial Support; Schering Plough – Financial Support; Thrombogenics – Financial Support; Steba Biotech – Consultant, Financial Support; Zeiss – Consultant, Financial Support.
Carl C. Awh – Arctic DX – Consultant, Equity Ownership/Stock Options; Bausch and Lomb – Consultant, Lecturer; Genentech – Consultant, Lecturer; Notal, Consultant; Synergetics; DX – Consultant, Equity Ownership/Stock Options, Patents/Royalties; Volk Optical, Consultant.
Sarah Gray – Genentech – Employee; Roche – Equity Ownership/Stock Options.
Namrata Saroj – Genentech – Employee; Roche – Equity Ownership/Stock Options.
Anthony P. Adamis – Genentech – Employee; Roche – Equity Ownership/Stock Options.
Wendy Yee Murahasi – Genentech – Employee; Roche – Equity Ownership/Stock Options.
Roman G. Rubio – Genentech – Employee; Roche – Equity Ownership/Stock Options.