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Questionnaire proves reliable in assessing visual function in patients with wet AMD

Invest Ophthalmol Vis Sci. 2009;50(8):3629-3635.

Issue: October 25, 2009

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A questionnaire was found to be a sensitive, dynamic measure of visual function in patients undergoing pharmacologic treatment for wet age-related macular degeneration.

"For patients, the effect of treatment on their ability to perform daily activities requiring high-acuity vision and on their emotional well-being may be as important as, or even more important, than the clinical measure of visual acuity," the study authors said.

Using data from the ANCHOR and MARINA phase 3 clinical studies of Lucentis (ranibizumab, Genentech), investigators examined the correlation between visual acuity results and patient scores on the National Eye Institute Visual Function Questionnaire (NEI VFQ-25).

The ANCHOR trial included 423 patients; the MARINA trial included 716 patients.

Investigators assigned patients to subgroups according to clinically meaningful changes in visual acuity from baseline to 12 months: 15 or more letters gained, less than 15 letters lost or gained, and 15 or more letters lost.

A 4- to 6-point change in NEI VFQ-25 composite scores and three subscale scores correlated with a 15-letter change in best corrected visual acuity.

Patients who gained 15 or more letters had the largest mean increase in NEI VFQ-25 scores. Patients who lost 15 or more letters had the largest mean decrease in scores. The mean change in composite score was 8.2 points among patients who gained 15 or more letters, 3 among those who gained or lost less than 15 letters, and -6.3 points among those who lost 15 or more letters.

In both studies, patients treated with ranibizumab were more likely than controls to report improvement in the subscales of near activities, distance activities and vision-specific dependency.

The study by Suner et al describes the combined results of the ANCHOR and MARINA trials on changes in the NEI VFQ-25 test. ANCHOR and MARINA were prospective trials comparing the use of intravitreal ranibizumab to either photodynamic therapy or observation in the treatment of wet age related macular degeneration. The NEI VFQ-25 is a questionnaire that subjectively measures a patient’s perception of their vision-related function. It was administered prior to treatment and at various intervals during the ANCHOR and MARINA trials. The critical importance of this study is that it confirms that a uniocular measure of visual function (best corrected Snellen acuity in the treated eye) highly correlates with a measure of binocular visual function as assessed by the NEI VFQ-25, and that the NEI VFQ-25 can independently correlate to clinically relevant differences in visual acuity.

– Jay S. Duker, MD
OSN Retina/Vitreous Board Member