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A Randomized Clinical Trial

Neil M. Bressler, MD; Tom S. Chang, MD; Jennifer T. Fine, ScD; Chantal M. Dolan, PhD; James Ward, PhD; for the Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration (ANCHOR) Research Group

Arch Ophthalmol. 2009;127(1):13-21.

Objective  To compare patient-reported visual function in those with neovascular age-related macular degeneration treated with ranibizumab or verteporfin photodynamic therapy (PDT).

Design  Multicenter, double-masked, phase 3 trial (ANCHOR). Participants were randomized in a 1:1:1 ratio to receive 0.3 or 0.5 mg of intravitreal ranibizumab plus sham verteporfin or sham injections plus active verteporfin monthly. The National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) was administered at baseline and 1, 2, 3, 6, 9, 12, 18, and 24 months.

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

Results  At 12 months, patients treated with ranibizumab (0.3 mg [n = 137] or 0.5 mg [n = 139]) had mean improvements in NEI VFQ-25 composite scores of 5.9 (95% confidence interval [CI], 3.6 to 8.3) and 8.1 (95% CI, 5.3 to 10.8) points, respectively; patients treated with PDT (n = 142) had a mean improvement of 2.2 points (95% CI, –0.3 to 4.7; vs 0.5 mg of ranibizumab, P < .001; vs 0.3 mg of ranibizumab, P = .003). At each dose through 24 months, patients treated with ranibizumab were more likely to improve in most subscales, including the prespecified subscales (near activities, distance activities, and vision-specific dependency).

Conclusions  Patients treated with ranibizumab were more likely to report clinically meaningful improvements in visual function through 24 months compared with those treated with verteporfin PDT.

Application to Clinical Practice  Ranibizumab treatment in neovascular age-related macular degeneration can improve patient-reported visual function.

Trial Registration  clinicaltrials.gov Identifier: NCT00061594

Author Affiliations: Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland (Dr Bressler); Retina Institute of California, Pasadena (Dr Chang); and Genentech Inc, South San Francisco, California (Drs Fine, Dolan, and Ward).
Group Information: A list of the ANCHOR Research Group members who contributed data for the patients enrolled in this clinical trial was published in N Engl J Med. 2006;355(14):1432-1444.

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