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Clinical Trials |

Improved Vision-Related Function After Ranibizumab Treatment of Neovascular Age-Related Macular Degeneration 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 ; MARINA Study Group
Arch Ophthalmol. 2007;125(11):1460-1469. doi:10.1001/archopht.125.11.1460.
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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: "http://clinicaltrials.gov/show/NCT00056836">NCT00056836

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Figure 1.

Mean change from baseline through 24 months in National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) score by treatment group for overall (composite) score (A), near activities (B), distance activities (C), and dependency (D). P values for comparison of ranibizumab dose groups with control are as follows. (A) Overall score, 0.3 mg vs sham: P = .01 at month 1, P < .001 at months 2 through 24; 0.5 mg vs sham: P > .05 at month 1, P = .04 at month 2, P < .001 at months 3 through 24. (B) Near activities, 0.3 mg vs sham: P = .05 at month 1, P = .004 at month 2, P < .001 at months 3 through 24; 0.5 mg vs sham: P = .04 at month 1, P = .03 at month 2, P < .001 at months 3 through 24. (C) Distance activities, 0.3 mg vs sham: P = .008 at month 1, P < .001 at months 2 through 24; 0.5 mg vs sham: P > .05 at month 1, P = .01 at month 2, P < .001 at months 3 through 24. (D) Dependency, 0.3 mg vs sham: P > .05 at month 1, P = .009 at month 2, P = .006 at month 3, P = .005 at month 6, P = .001 at month 9, P < .001 at months 12 through 24; 0.5 mg vs sham: P > .05 at month 1, P = .02 at month 2, P = .001 at month 3, P < .001 at months 6 through 24.

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Figure 2.

Percentage with improvement of 10 or more points (left side) or loss of 10 or more points from baseline to 12 months (light gray bars) or 24 months (dark gray bars) on the National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) overall (composite) score (A), near activities (B), distance activities (C), and dependency (D) by treatment group. P values for comparison of ranibizumab dose groups with control are from Pearson χ2 tests as follows: P < .001 for all comparisons of 0.3 mg or 0.5 mg vs sham with the single exception of dependency, 10 or greater point loss at month 12, 0.3 mg vs sham: P = .02.

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Figure 3.

Time to first gain of at least 10 or more points from baseline sustained at the next or last qualifying visit (Kaplan-Meier estimates) by treatment group for National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) overall (composite) score (A), near activities (B), distance activities (C), and dependency (D) by treatment group.

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