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Clinical Trials |

Improved Vision-Related Function After Ranibizumab vs Photodynamic Therapy:  A Randomized Clinical Trial

Neil M. Bressler, MD; Tom S. Chang, MD; Jennifer T. Fine, ScD; Chantal M. Dolan, PhD; James Ward, PhD ; 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. doi:10.1001/archophthalmol.2008.562.
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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

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Figure 1.

Mean change from baseline through 24 months in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) subscale scores by treatment group. Vertical lines represent ±1 standard error. The number of patients in the photodynamic therapy (PDT) and 0.3-mg and 0.5-mg ranibizumab groups were 142, 137, and 139, respectively, for all subscales, except the driving subscale (n = 120, n = 117, and n = 127, respectively). For a comparison of ranibizumab-dose groups with PDT at 12 and 24 months, see Pvalues in eTable 1).

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Figure 2.

Percentage of patients with improvement of 10 or more points or loss of 10 or more points from baseline to 12 or 24 months in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) subscale scores by treatment group. The number of patients in the photodynamic therapy (PDT) and 0.3-mg and 0.5-mg ranibizumab groups were 142, 137, and 139, respectively, for all subscales, except the driving subscale (n = 120, n = 117, and n = 127, respectively). For a comparison of ranibizumab-dose groups with PDT at 12 and 24 months, see Pvalues in eTable 2.

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Figure 3.

Time to first gain of 10 or more points on the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) from baseline to the next qualifying visit or last qualifying visit across 24 months (Kaplan-Meier estimates) by treatment group. PDT indicates photodynamic therapy.

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