Faculty Collaboration Database

Improved vision-related function after ranibizumab treatment of neovascular age-related macular degeneration: results of a randomized clinical trial. Arch Ophthalmol 2007 Nov;125(11):1460-9

Date

11/14/2007

Pubmed ID

17998507

DOI

10.1001/archopht.125.11.1460

Scopus ID

2-s2.0-36148980784 (requires institutional sign-in at Scopus site)   203 Citations

Abstract

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: NCT00056836.

Author List

Chang TS, Bressler NM, Fine JT, Dolan CM, Ward J, Klesert TR, MARINA Study Group

Author

Thomas B. Connor MD Professor in the Ophthalmology and Visual Sciences department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Aged
Aged, 80 and over
Angiogenesis Inhibitors
Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Choroidal Neovascularization
Disease Progression
Double-Blind Method
Female
Fluorescein Angiography
Follow-Up Studies
Humans
Injections
Macular Degeneration
Male
Middle Aged
Prospective Studies
Ranibizumab
Retreatment
Sickness Impact Profile
Surveys and Questionnaires
Treatment Outcome
Vascular Endothelial Growth Factor A
Visual Acuity
Vitreous Body