Purchase this article with an account.
S.M. Shah, Q.D. Nguyen, S. Harriprisad, K. Chu, N. Holekamp, J. Buskey, D. Nadler, J. Cederbaum, P.A. Campochiaro; A Double–Masked, Placebo–Controlled, Safety, and Tolerability Study of Intravenous VEGF Trap in Patients With Diabetic Macular Edema . Invest. Ophthalmol. Vis. Sci. 2006;47(13):3850.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To determine the safety, tolerability, and bioactivity of 4 intravenous (IV) infusions of VEGF Trap in patients with diabetic macular edema (DME).
The trial was designed as a dose–escalation study investigating 0.3, 1.0, and 3.0 mg/kg of IV VEGF Trap. A simultaneous trial for neovascular AMD showed hypertension in patients receiving 3.0 mg/kg; therefore, the DME trial was limited to the 0.3 mg/kg dose. Nine patients with DME, foveal thickness ≥ 250 µm measured by optical coherence tomography (OCT), and ETDRS best–corrected visual acuity (BCVA) of ≤ 20/40 were randomized 3:1 to receive 0.3 mg/kg VEGF Trap or placebo. Safety assessments included eye examinations, vital signs, and laboratory tests (including measurement of antibodies to VEGF Trap). Primary outcome was change in excess foveal thickness (EFT); secondary outcomes were BCVA and assessment of leakage by fluorescein angiography (FA).
Six patients received 0.3 mg/kg VEGF Trap IV; and 3 placebo. One placebo subject did not complete the study. Mean age (5 females, 4 males) was 68 years. No evidence of increased urine protein or elevated blood pressure was observed. No ocular adverse events were reported. No patients developed antibodies to VEGF Trap. Three treated patients improved by two lines, with a corresponding decrease in EFT and leakage by FA. EFT decreased after each dose of VEGF Trap, with sustained improvement after the last of the 4 bi–weekly doses. Mean EFT decreased by 42% (144 versus 251µm at baseline) in the VEGF Trap group and increased by 32% (509 versus 344 µm at baseline) in 2 placebo patients.
Intravenous VEGF Trap was well–tolerated at a dose of 0.3 mg/kg and led to reduction in EFT. The study provides proof of concept for use of VEGF Trap in DME; additional studies are planned to evaluate the effect of intravitreous administration.
This PDF is available to Subscribers Only