Vision-Related Function after Ranibizumab Treatment by Better- or Worse-Seeing Eye

Objective To examine the effects of ranibizumab on the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) scores in neovascular age-related macular degeneration (AMD) according to whether the study eye was the better- or worse-seeing eye at baseline. Design Within 2 randomized, dou...

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Published inOphthalmology (Rochester, Minn.) Vol. 117; no. 4; pp. 747 - 756.e4
Main Authors Bressler, Neil M., MD, Chang, Tom S., MD, Suñer, Ivan J., MD, Fine, Jennifer T., ScD, Dolan, Chantal M., PhD, Ward, James, PhD, Ianchulev, Tsontcho, MD, MPH
Format Journal Article
LanguageEnglish
Published Elsevier Inc 01.04.2010
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Summary:Objective To examine the effects of ranibizumab on the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) scores in neovascular age-related macular degeneration (AMD) according to whether the study eye was the better- or worse-seeing eye at baseline. Design Within 2 randomized, double-masked clinical trials (MARINA and ANCHOR), the NEI VFQ-25 was administered at 0, 1, 2, 3, 6, 9, 12, 18, and 24 months. Participants We included 646 MARINA and 379 ANCHOR patients. Intervention Patients were randomized 1:1:1 to monthly intravitreal ranibizumab (0.3 or 0.5 mg) or control (sham injections for MARINA; photodynamic therapy [PDT] with verteporfin for ANCHOR). Main Outcome Measures Mean change from baseline in NEI VFQ-25 scores at 12 and 24 months. Results Across all treatment arms, 21% to 38% of enrolled eyes were the better-seeing eye. At the 24-month follow-up visit, mean change in composite scores with ranibizumab seemed to be better than control for both better-seeing eyes (8.4 [95% confidence interval (CI), 5.2–11.6], 7.5 [95% CI, 3.7–11.4], and −9.4 [95% CI, −12.5 to −6.3] for the 0.3-mg, 0.5-mg, and sham groups, respectively) and worse-seeing eyes (1.7 [95% CI, −1.1 to 4.4], 1.7 [95% CI, −0.7 to 4.1], and −5.4 [95% CI, −7.9 to −2.8] for the 0.3-mg, 0.5-mg, and sham groups, respectively) in MARINA, as well as the better-seeing eye in ANCHOR (11.3 [95% CI, 5.3–17.3], 13.3 [95% CI, 7.7–19.0], and −2.7 [95% CI, −9.0 to 3.7] for the 0.3-mg, 0.5-mg, and PDT groups, respectively). When the worse-seeing eye was treated in ANCHOR, such differences could not be detected at 24 months (1.3 [95% CI, −1.7 to 4.2], 2.6 [95% CI, −1.1 to 6.3], and 0.1 [95% CI, −3.5 to 3.7] for the 0.3-mg, 0.5-mg, and PDT groups, respectively). Conclusions Analysis of patient perception of vision-related function in phase III trials evaluating ranibizumab for neovascular AMD demonstrates improved patient-reported outcomes regardless of whether the treated eye is the better- or worse-seeing eye at onset of treatment, and supports treatment of such lesions with ranibizumab, even those in the worse-seeing eye. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.
ISSN:0161-6420
1549-4713
DOI:10.1016/j.ophtha.2009.09.002