A Phase 2/3, Multicenter, Randomized, Double-Masked, 2-Year Trial of Pegaptanib Sodium for the Treatment of Diabetic Macular Edema

• Published in: Ophthalmology (Rochester, Minn.) Vol. 118; no. 6; pp. 1107 - 1118
• Main Authors: Sultan, Marla B., Zhou, Duo, Loftus, Jane, Dombi, Theresa, Ice, Kathleen S.
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.06.2011; Elsevier
• Subjects: Adult; Aged; Aged, 80 and over; Aptamers, Nucleotide - administration & dosage; Biological and medical sciences; Diabetes. Impaired glucose tolerance; Diabetic Retinopathy - complications; Diabetic Retinopathy - drug therapy; Diabetic Retinopathy - physiopathology; Dose-Response Relationship, Drug; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Etiopathogenesis. Screening. Investigations. Target tissue resistance; Female; Fluorescein Angiography; Fundus Oculi; Humans; Intravitreal Injections; Macula Lutea - pathology; Macular Edema - drug therapy; Macular Edema - etiology; Macular Edema - physiopathology; Male; Medical sciences; Middle Aged; Miscellaneous; Ophthalmology; Retinopathies; Treatment Outcome; Vascular Endothelial Growth Factor A; Visual Acuity; Young Adult; Endocrinopathy; Retinopathy; Phase; Diabetes mellitus; Mask; Retinal edema; Pegaptanib; Eye disease; Vascular endothelium growth factor; Treatment; Sodium; Oligonucleotide; Ophthalmology; Pegylated form; Antiangiogenic agent

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. Randomized (1:1), sham-controlled, multicenter, parallel-gr...