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Ophthalmology. 2011 Sep;118(9):1819-26. doi: 10.1016/j.ophtha.2011.02.018. Epub 2011 May 5.

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

Author information

1
Wilmer Eye Institute, Department of Ophthalmology, Johns Hopkins University, Baltimore, Maryland, USA. ddo@jhmi.edu

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.

Comment in

PMID:
21546089
DOI:
10.1016/j.ophtha.2011.02.018
[Indexed for MEDLINE]

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