April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
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
Author Affiliations & Notes
  • Jane V. Loftus
    Outcomes Research, Pfizer Ltd London, Walton-on-the Hill Tadworth Surrey, United Kingdom
  • Andreas M. Pleil
    Worldwide Med & Outcomes Rsch, Pfizer Inc, San Diego, California
  • Macugen 1013 Study Group
    Outcomes Research, Pfizer Ltd London, Walton-on-the Hill Tadworth Surrey, United Kingdom
  • Footnotes
    Commercial Relationships  Jane V. Loftus, Pfizer (E); Andreas M. Pleil, Pfizer (E)
  • Footnotes
    Support  Research supported by Pfizer Inc.
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 564. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : To assess the changes in VRQoL in DME patients treated with intravitreous pegaptanib 0.3 mg versus sham injection at two years.

Methods: : 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).

Results: : 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.

Conclusions: : 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.

Clinical Trial: : http://www.clinicaltrials.gov NCT00605280

Keywords: visual acuity • quality of life • diabetic retinopathy 
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