Changes in Vision- and Health-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Pegaptanib Sodium or Sham

• Published in: Investigative ophthalmology & visual science Vol. 52; no. 10; p. 7498
• Main Authors: Loftus, Jane V., Sultan, Marla B., Pleil, Andreas M.
• Format: Journal Article
• Language: English
• Published: United States 29.09.2011
• Subjects: Adult; Aged; Aged, 80 and over; Aptamers, Nucleotide - therapeutic use; Diabetic Retinopathy - drug therapy; Diabetic Retinopathy - physiopathology; Double-Blind Method; Female; Humans; Macular Edema - drug therapy; Macular Edema - physiopathology; Male; Middle Aged; Quality of Life; Sickness Impact Profile; Surveys and Questionnaires; Tomography, Optical Coherence; Treatment Outcome; Vision, Ocular - physiology; Visual Acuity - physiology; Young Adult
• ISSN: 1552-5783; 1552-5783
• DOI: 10.1167/iovs.11-7613

To compare vision function and self-reported quality of life (QoL) in patients with diabetic macular edema (DME) treated with intravitreous pegaptanib 0.3 mg or sham injection. 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 pre-specified criteria in year 2. Primary efficacy endpoint: proportion gaining ≥10 letters of VA from baseline to week 54. Change in QoL from baseline to weeks 54 and 102 was assessed with the 25-item National Eye Institute-Visual Function Questionnaire (NEI-VFQ 25) and the EQ-5D. One hundred thirty-three pegaptanib- and 127 sham-treated subjects were in the year 1 intent-to-treat population. From baseline to week 54, ≥ 10 letter gains 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). At 2 years, the VA trend favored pegaptanib. The NEI-VFQ 25 domains of Near Vision, Distance Vision, and Social Functioning (week 54) and Distance Vision, Social Functioning, Mental Health, and Composite Score (week 102) demonstrated clinically meaningful (>5-point between-group difference) and statistically significant (P < 0.05) benefits favoring pegaptanib. No significant difference in the mean change in generic EQ-5D-weighted utility scores was seen. The VA improvement from pegaptanib treatment versus sham is reflected by improved vision-related QoL as reported by the DME patient (ClinicalTrials.gov number, NCT00605280).