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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
Author(s) -
LOFTUS J,
PLEIL A
Publication year - 2010
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2010.4113.x
Subject(s) - pegaptanib , medicine , clinical endpoint , visual acuity , population , randomized controlled trial , quality of life (healthcare) , ophthalmology , surgery , ranibizumab , bevacizumab , environmental health , nursing , chemotherapy
Purpose To compare self‐reported vision functioning and vision related‐QoL in patients with DME treated with intravitreous pegaptanib 0.3 mg versus sham injection. Methods This randomized (1:1), controlled, multicenter trial included subjects with DME (center point thickness on OCT ≥250 µm) and visual acuity (VA) ≤65 letters and ≥35 letters. In Year 1, pegaptanib or sham was administered every 6 weeks with focal/grid photocoagulation at investigator discretion after week 18. Subjects received injections as often as every 6 weeks per prespecified criteria in Year 2. The primary efficacy endpoint was the proportion gaining ≥10 letters from baseline to week 54. Change in visual functioning from baseline to Weeks 54 was assessed with the National Eye Institute – Visual Functioning Questionnaire. Results 133 pegaptanib‐ and 127 sham‐treated subjects were in the Year 1 modified intent‐to‐treat population. From baseline to Week 54, gains of ≥10 letters were seen 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). The subscales of Near Vision, Distance Vision, and Social Functioning (Week 54) demonstrated clinically meaningful (>5‐point between‐group difference) and statistically significant (P<0.05) benefits favoring pegaptanib. A positive numerical trend in favour of pegaptanib was observed for the Composite Score and the majority of other subscales. Conclusion The vision improvement from pegaptanib treatment compared to sham is associated with improved visual functioning as reported by the DME patient.Commercial interest