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A phase 2/3, multicenter, randomized, double-masked, 2-year trial of pegaptanib sodium for the treatment of diabetic macular edema
- Source :
- Ophthalmology, 118, 6, pp. 1107-18, Ophthalmology, 118, 1107-18
- Publication Year :
- 2011
-
Abstract
- Item does not contain fulltext PURPOSE: To confirm the safety and compare the efficacy of intravitreal pegaptanib sodium 0.3 mg versus sham injections in subjects with diabetic macular edema (DME) involving the center of the macula associated with vision loss not due to ischemia. DESIGN: Randomized (1:1), sham-controlled, multicenter, parallel-group trial. PARTICIPANTS: Subjects with DME. INTERVENTION: Subjects received pegaptanib 0.3 mg or sham injections every 6 weeks in year 1 (total = 9 injections) and could receive focal/grid photocoagulation beginning at week 18. During year 2, subjects received injections as often as every 6 weeks per prespecified criteria. MAIN OUTCOME MEASURES: The primary efficacy endpoint was the proportion gaining >/= 10 letters of visual acuity (VA) from baseline to year 1. Safety was monitored throughout. RESULTS: In all, 260 (pegaptanib, n = 133; sham, n = 127) and 207 (pegaptanib, n = 107; sham, n = 100) subjects were included in years 1 and 2 intent-to-treat analyses, respectively. A total of 49 of the 133 (36.8%) subjects from the pegaptanib group and 25 of the 127 (19.7%) from the sham group experienced a VA improvement of >/= 10 letters at week 54 compared with baseline (odds ratio [OR], 2.38; 95% confidence interval, 1.32-4.30; P = 0.0047). For pegaptanib-treated subjects, change in mean VA from baseline by visit was superior (P
- Subjects :
- Adult
Male
Vascular Endothelial Growth Factor A
medicine.medical_specialty
Visual acuity
Fundus Oculi
Pegaptanib
Eye disease
Population
Visual Acuity
Macular Edema
law.invention
Young Adult
Randomized controlled trial
law
Ophthalmology
Evaluation of complex medical interventions Genomic disorders and inherited multi-system disorders [NCEBP 2]
medicine
Pegaptanib Sodium
Humans
Macula Lutea
Fluorescein Angiography
Adverse effect
education
Aged
Aged, 80 and over
education.field_of_study
Diabetic Retinopathy
Dose-Response Relationship, Drug
business.industry
Aptamers, Nucleotide
Middle Aged
medicine.disease
Clinical trial
Treatment Outcome
Anesthesia
Intravitreal Injections
Female
medicine.symptom
business
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 01616420
- Database :
- OpenAIRE
- Journal :
- Ophthalmology, 118, 6, pp. 1107-18, Ophthalmology, 118, 1107-18
- Accession number :
- edsair.doi.dedup.....ca12d5e116c836fbe1935d6ad645a888