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Pegaptanib In Diabetic Macular Edema (DME): Vision Related Quality Of Life (QoL) Results From A Phase 2/3, 2-Year, Double-Masked Trial 1. Paul Mitchell¹ ¹Centre for Vision Research, Westmead Millennium Institute, University of Sydney, Australia Purpose: A meta-analysis reported that even in the presence of better diabetes treatment, diabetic eye disease continues to be a challenge. Self-reported vision functioning and vision-related QoL are strongly impacted by DME. This study compares QoL outcomes in DME patients receiving intravitreous pegaptanib 0.3 mg versus sham injection. Methods: This randomized (1:1) multicenter trial included subjects with DME (OCT center point thickness ≥250 µm) and visual acuity (VA) ≤65 and ≥35 letters. Pegaptanib or sham was administered every 6 weeks with laser at investigator discretion after Week 18. Primary efficacy endpoint was the proportion gaining ≥10 letters from baseline to Week 54. The National Eye Institute Visual Functioning Questionnaire (NEI VFQ25) assessed change in visual functioning from baseline to Week 54. Second year endpoints are not reported here. Results: 133 pegaptanib- and 127 sham-treated subjects comprised the modified intent-to-treat population (Year 1). From baseline to Week 54, gains of ≥10 letters occurred in 49 (36.8%) pegaptanib- and 25 (19.7%) sham-treated subjects (odds ratio [95% CI]: 2.38 [1.32,4.30], P=0.0047). At Week 54, the Near Vision, Distance Vision, and Social Functioning subscales demonstrated significant benefits favoring pegaptanib. Least square mean differences for pegaptanib–sham in change from baseline were 5.70 (P=0.0325), 8.50 (P=0.0040), 7.99 (P=0.0023), respectively. Positive numerical trends favoring pegaptanib were observed for the Composite Score and most other subscales. Conclusions: The study met its primary endpoint. Pegaptanib 0.3 mg was effective and well tolerated. The vision improvement from pegaptanib treatment was associated with improved patient-reported visual functioning in DME. |
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