Abstract
Purpose :
Research has led to a better clinical understanding of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), but little is known about its burden from the patient perspective. No single comprehensive disease-specific questionnaire currently exists to assess health-related quality of life (HRQoL) for this population. In order to gain insight into the effects of visual acuity impairment associated with moderate to severe GA secondary to AMD, the NEI-VFQ, a patient-reported outcomes questionnaire, was interviewer-administered to each subject.
Methods :
Based on a literature review, including available PRO measures, and qualitative research conducted with 18 patients and 9 retinal surgeons in the United States, the NEI-VFQ was found to map closely with the symptoms and impacts experienced by patients. In addition, its content was found to be clear and relevant to this population.
As part of a recent Phase 1/2a multicenter, randomized, single dose, dose escalation, fellow-eye controlled study, NEI-VFQ scores at baseline were computed for each of the subscales and the total composite score. Scores range from 0 to 100, and are calculated as an unweighted average of the included items, with higher scores representing better functioning.
Results :
32 subjects (53% female, mean age 81 + 7, mean maximum reading speed in treated eye 32 + 35 wpm, GA area 16 + 9 m2) with moderate to severe GA secondary to AMD completed the NEI-VFQ at baseline. Subjects reported decrements in many subscales of the NEI-VFQ. The lowest scores were reported for general vision (eyesight), near activities (difficulty with close up activities), role difficulties (impact in being able to accomplish things and activity limitations) and driving (for those subjects still driving) (see Table 1).
Conclusions :
Results from this study provide valuable preliminary findings on the burden associated with geographic atrophy secondary to age-related macular degeneration. In addition to impacts in general vision, decrements in many areas of HRQoL are also associated with this progressive disease.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.