alexa The DA VINCI Study: phase 2 primary results of VEGF Trap-Eye in patients with diabetic macular edema.
Genetics & Molecular Biology

Genetics & Molecular Biology

Journal of Molecular and Genetic Medicine

Author(s): Do DV, SchmidtErfurth U, Gonzalez VH, Gordon CM, Tolentino M,

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Abstract PURPOSE: To determine whether different doses and dosing regimens of intravitreal vascular endothelial growth factor (VEGF) Trap-Eye are superior to focal/grid photocoagulation in eyes with diabetic macular edema (DME). DESIGN: Multicenter, randomized, double-masked, phase 2 clinical trial. PARTICIPANTS: A total of 221 diabetic patients with clinically significant macular edema involving the central macula. METHODS: Patients were assigned to 1 of 5 treatment regimens: 0.5 mg VEGF Trap-Eye every 4 weeks; 2 mg VEGF Trap-Eye every 4 weeks; 2 mg VEGF Trap-Eye for 3 initial monthly doses and then every 8 weeks; 2 mg VEGF Trap-Eye for 3 initial monthly doses and then on an as-needed (PRN) basis; or macular laser photocoagulation. Assessments were completed at baseline and every 4 weeks thereafter. MAIN OUTCOME MEASURES: Mean change in visual acuity and central retinal thickness (CRT) at 24 weeks. RESULTS: Patients in the 4 VEGF Trap-Eye groups experienced mean visual acuity benefits ranging from +8.5 to +11.4 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters versus only +2.5 letters in the laser group (P ≤ 0.0085 for each VEGF Trap-Eye group vs. laser). Gains from baseline of 0+, 10+, and 15+ letters were seen in up to 93\%, 64\%, and 34\% of VEGF Trap-Eye groups versus up to 68\%, 32\%, and 21\% in the laser group, respectively. Mean reductions in CRT in the 4 VEGF Trap-Eye groups ranged from -127.3 to -194.5 μm compared with only -67.9 μm in the laser group (P = 0.0066 for each VEGF Trap-Eye group vs. laser). VEGF Trap-Eye was generally well tolerated. Ocular adverse events in patients treated with VEGF Trap-Eye were generally consistent with those seen with other intravitreal anti-VEGF agents. CONCLUSIONS: Intravitreal VEGF Trap-Eye produced a statistically significant and clinically relevant improvement in visual acuity when compared with macular laser photocoagulation in patients with DME. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. This article was published in Ophthalmology and referenced in Journal of Molecular and Genetic Medicine

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