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Results of a Randomized Clinical Trial

Tom S. Chang, MD; Neil M. Bressler, MD; Jennifer T. Fine, ScD; Chantal M. Dolan, PhD; James Ward, PhD; Todd R. Klesert, MD, PhD; for the MARINA Study Group

Arch Ophthalmol. 2007;125(11):1460-1469.

Objective  To examine the effects of ranibizumab on patient-reported visual function using the National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) in patients with neovascular age-related macular degeneration (AMD).

Design  In MARINA, a randomized, double-masked clinical trial, 716 patients with AMD with recent disease progression and minimally classic or occult with no classic lesion component were randomized 1:1:1 to monthly intravitreal ranibizumab (0.3 or 0.5 mg) or sham injections. The NEI VFQ-25 was administered at 0, 1, 2, 3, 6, 9, 12, 18, and 24 months.

Main Outcome Measure  Mean change from baseline in NEI VFQ-25 scores at 12 and 24 months.

Results  At 12 months, ranibizumab-treated patients (0.3 mg [n = 238] and 0.5 mg [n = 240]) had mean improvements in NEI VFQ-25 composite scores of +5.2 (95% confidence interval [CI], 3.5 to 6.9) and +5.6 (95% CI, 3.9 to 7.4), respectively; sham-injected patients (n = 238) had a mean decline of –2.8 (95% CI, –4.6 to –1.1; P < .001 vs each dose). Ranibizumab-treated patients were more likely to improve in near activities, distance activities, and vision-specific dependency through 24 months.

Conclusions  In MARINA, ranibizumab-treated patients were more likely than sham-treated patients to report visual function improvements at 12 and 24 months.

Application to Clinical Practice  Treatment of neovascular AMD with ranibizumab can improve patient-reported visual function in a meaningful way compared with sham treatments.

Trial Registration  clinicaltrials.gov Identifier: NCT00056836

Author Affiliations: Retina Institute of California, Pasadena (Dr Chang); Retina Division, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland (Dr Bressler); Genentech, Inc, South San Francisco, California (Drs Fine, Dolan, and Ward); and Doheny Retina Institute, University of Southern California, Los Angeles (Dr Klesert).

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