Document Detail


One-year outcomes of the da Vinci Study of VEGF Trap-Eye in eyes with diabetic macular edema.
MedLine Citation:
PMID:  22537617     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: To compare different doses and dosing regimens of Vascular Endothelial Growth Factor (VEGF) Trap-Eye with laser photocoagulation in eyes with diabetic macular edema (DME).
DESIGN: Randomized, double-masked, multicenter, phase 2 clinical trial.
PARTICIPANTS: Diabetic patients (n = 221) with center-involved DME.
METHODS: Participants were assigned randomly to 1 of 5 treatment regimens: VEGF Trap-Eye 0.5 mg every 4 weeks (0.5q4); 2 mg every 4 weeks (2q4); 2 mg every 8 weeks after 3 initial monthly doses (2q8); or 2 mg dosing as needed after 3 initial monthly doses (2PRN), or macular laser photocoagulation.
MAIN OUTCOME MEASURES: The change in best-corrected visual acuity (BCVA) at 24 weeks (the primary end point) and at 52 weeks, proportion of eyes that gained 15 letters or more in Early Treatment of Diabetic Retinopathy Study (ETDRS) BCVA, and mean changes in central retinal thickness (CRT) from baseline.
RESULTS: As previously reported, mean improvements in BCVA in the VEGF Trap-Eye groups at week 24 were 8.6, 11.4, 8.5, and 10.3 letters for 0.5q4, 2q4, 2q8, and 2PRN regimens, respectively, versus 2.5 letters for the laser group (P ≤ 0.0085 versus laser). Mean improvements in BCVA in the VEGF Trap-Eye groups at week 52 were 11.0, 13.1, 9.7, and 12.0 letters for 0.5q4, 2q4, 2q8, and 2PRN regimens, respectively, versus -1.3 letters for the laser group (P ≤ 0.0001 versus laser). Proportions of eyes with gains in BCVA of 15 or more ETDRS letters at week 52 in the VEGF Trap-Eye groups were 40.9%, 45.5%, 23.8%, and 42.2% versus 11.4% for laser (P = 0.0031, P = 0.0007, P = 0.1608, and P = 0.0016, respectively, versus laser). Mean reductions in CRT in the VEGF Trap-Eye groups at week 52 were -165.4 μm, -227.4 μm, -187.8 μm, and -180.3 μm versus -58.4 μm for laser (P < 0.0001 versus laser). Vascular Endothelial Growth Factor Trap-Eye generally was well tolerated. The most frequent ocular adverse events with VEGF Trap-Eye were conjunctival hemorrhage, eye pain, ocular hyperemia, and increased intraocular pressure, whereas common systemic adverse events included hypertension, nausea, and congestive heart failure.
CONCLUSIONS: Significant gains in BCVA from baseline achieved at week 24 were maintained or improved at week 52 in all VEGF Trap-Eye groups. Vascular Endothelial Growth Factor Trap-Eye warrants further investigation for the treatment of DME.
Authors:
Diana V Do; Quan Dong Nguyen; David Boyer; Ursula Schmidt-Erfurth; David M Brown; Robert Vitti; Alyson J Berliner; Bo Gao; Oliver Zeitz; Rene Ruckert; Thomas Schmelter; Rupert Sandbrink; Jeff S Heier;
Publication Detail:
Type:  Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-04-24
Journal Detail:
Title:  Ophthalmology     Volume:  119     ISSN:  1549-4713     ISO Abbreviation:  Ophthalmology     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-08-03     Completed Date:  2012-10-25     Revised Date:  2013-09-20    
Medline Journal Info:
Nlm Unique ID:  7802443     Medline TA:  Ophthalmology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1658-65     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Affiliation:
Wilmer Eye Institute, Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. ddo@jhmi.edu
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MeSH Terms
Descriptor/Qualifier:
Diabetes Mellitus, Type 1 / complications
Diabetes Mellitus, Type 2 / complications
Diabetic Retinopathy / drug therapy,  physiopathology,  surgery,  therapy*
Double-Blind Method
Female
Humans
Laser Coagulation*
Macular Edema / drug therapy,  physiopathology,  surgery,  therapy*
Male
Middle Aged
Recombinant Fusion Proteins / administration & dosage*,  therapeutic use
Retreatment
Treatment Outcome
Visual Acuity / physiology
Chemical
Reg. No./Substance:
0/Recombinant Fusion Proteins; 15C2VL427D/aflibercept

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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