Vision-Related Function after Ranibizumab Treatment by Better- or Worse-Seeing Eye: Clinical TriaL Results from MARINA and ANCHOR

• Published in: Ophthalmology (Rochester, Minn.) Vol. 117; no. 4; pp. 747 - 756
• Main Authors: BRESSLER, Neil M, CHANG, Tom S, SUNER, Ivan J, FINE, Jennifer T, DOLAN, Chantal M, WARD, James, IANCHULEV, Tsontcho
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier 01.04.2010
• Subjects: Aged; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal, Humanized; Biological and medical sciences; Choroidal Neovascularization - drug therapy; Choroidal Neovascularization - physiopathology; Double-Blind Method; Female; Follow-Up Studies; Humans; Injections; Macular Degeneration - drug therapy; Macular Degeneration - physiopathology; Male; Medical sciences; Miscellaneous; Ophthalmology; Photochemotherapy; Photosensitizing Agents - administration & dosage; Porphyrins - administration & dosage; Ranibizumab; Sickness Impact Profile; Surveys and Questionnaires; Visual Acuity - physiology; Vitreous Body; Immunomodulator; Eye; Vascular endothelium growth factor; Treatment; Vision; Ranibizumab; Clinical trial; Monoclonal antibody; Ophthalmology; Antiangiogenic agent
• DOI: 10.1016/j.ophtha.2009.09.002
• ISSN: 0161-6420

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. 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. We included 646 MARINA and 379 ANCHOR patients. 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). Mean change from baseline in NEI VFQ-25 scores at 12 and 24 months. 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). 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. Proprietary or commercial disclosure may be found after the references.