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Jane V. Loftus, Andreas M. Pleil, Macugen 1013 Study Group; Pegaptanib In Diabetic Macular Edema (DME): Vision-Related Quality of Life (VRQoL) Results at Two Years from a Phase 2/3, 2-year, Randomized (1:1), Sham-Controlled, Double-Masked Trial. Invest. Ophthalmol. Vis. Sci. 2011;52(14):564.
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To assess the changes in VRQoL in DME patients treated with intravitreous pegaptanib 0.3 mg versus sham injection at two years.
This multicenter trial included subjects with DME (center point thickness on OCT ≥250 µm) and visual acuity (VA) ≤65 letters and ≥35 letters. Focal/grid photocoagulation was permitted at investigator discretion after Week 18; pegaptanib intravitreal injection or sham was administered every six weeks for the first year and as often as once every six weeks per pre-specified criteria in Year 2. Change in VRQoL (baseline to Week 102) was assessed with the National Eye Institute -Visual Functioning Questionnaire 25 (NEI-VFQ). Change in utility (baseline to Week 102) was assessed using the EuroQol questionnaire (EQ-5D).
The modified intent-to treat (LOCF) Year 2 population included 107 pegaptanib- and 100 sham-treated subjects. The NEI-VFQ subscales of Distance Vision, Social Functioning, and Mental Health, and the Composite Score (Week 102) were clinically meaningful and statistically significant (P<0.05) in favor of pegaptanib over sham. Other subscales showed various degrees of numeric, but not statistical, differences in favor of pegaptanib. The EQ-5D was unresponsive to changes in VRQoL and remained stable in both groups over the two-year period.
Vision improvement from pegaptanib treatment compared to sham is associated with improved VRQoL using the NEI-VFQ as reported by the DME patient over two years. The EQ-5D instrument may be insufficiently sensitive to detect differences in this population.
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