Abstract
Purpose: :
To measure baseline self-reported vision functioning and related QoL of patients with NV-AMD based on the characteristics of the CNV lesion (early vs. established).
Methods: :
The baseline population of a Phase 3b/4, open-label, multicenter trial (NCT00327470) of Macugen 0.3mg was included in this analysis: 285 subjects (107 with early + 178 with established lesions) from Canada and 14 European countries. Early lesions were defined as occult with classic in <50% of the total lesion, no subfoveal retinal hemorrhage, lipid exudation, or retinal pigment epithelial detachment, and baseline visual acuity ≥54 ETDRS letters or equivalent. All others were classified as established. Patients completed the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and the EuroQol Group’s EQ-5D (EQ-5D) by telephone interview during the 2 weeks before their first Macugen injection.
Results: :
Baseline mean NEI-VFQ-25 composite scores were 72.5 and 64.5 for early and established CNV groups, respectively. For baseline mean scores of the subscales, both groups reported relatively poor general health and vision, near and distance vision activities, and mental health, and role difficulties; they tended to have less problem with ocular pain, social functioning, dependency, color vision and peripheral vision. When comparing baseline mean scores between groups, the subjects with early lesions had higher scores for the composite and for all vision-related subscales except the driving subscale (the established group had slightly higher score); the between-group differences were small for the general health, ocular pain, and driving subscales. EQ-5D index scores were similar (0.74 and 0.72 for early and established CNV groups, respectively), suggesting similar health status between groups.
Conclusions: :
These data suggest that, at study initiation, though the 2 groups had similar general health status, patients with early lesions tended to have better vision functioning. The result is not unexpected and supports the progressive nature of NV-AMD and its impact on functioning from a patient’s perspective.
Clinical Trial: :
www.clinicaltrials.gov NCT00327470
Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • quality of life