Analysis confirms responsiveness of NEI VFQ-25 to changes in BCVA in RIDE, RISE studies

Researchers analyzing data from the RIDE and RISE studies confirmed the responsiveness of the National Eye Institute Visual Function Questionnaire-25 in patients with diabetic macular edema, according to a study.

The phase 3 RIDE and RISE studies evaluated the efficacy and safety of intravitreal Lucentis (ranibizumab, Genentech) in patients with diabetic macular edema. Patients received monthly intravitreal ranibizumab 0.3 mg or 0.5 mg or a sham injection for 2 years. The NEI VFQ-25 questionnaire was administered to the entire cohort at baseline and at months 6, 12, 18 and 24. The questionnaire included 25 questions within 11 vision subscales, and the scoring ranged from 0 (worst) to 100 (best).

Subjects were grouped according to the change in best corrected visual acuity from baseline to 24 months: 15 or more letters gained, 15 or more letters lost, or less than 15 letters gained or lost.

The mean improvement in NEI VFQ-25 composite score for a gain of 15 letters or more was 9 points in the RIDE cohort and 7.1 points in the RISE cohort. For patients who lost 15 letters or more, the decrease was 6.6 points in the RIDE cohort and 2.7 points in the RISE cohort.

“This exploratory analysis confirms the responsiveness of the NEI VFQ-25 instrument to changes in best corrected visual acuity over time in two independent studies,” the study authors said.

Disclosure: Suñer reports he is a consultant for Bausch + Lomb, Eyetech, Genentech, Optos and Pfizer and is on the medical advisory board for Optos. See the full study for all other authors’ relevant financial disclosures.

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Source:

Suñer IJ, et al. Retina. 2016;doi:10.1097/IAE.0000000000001316.