A phase I study of intravitreal vascular endothelial growth factor trap-eye in patients with neovascular age-related macular degeneration.

Published

Journal Article

PURPOSE: To determine the safety, tolerability, maximum tolerated dose, and bioactivity of an intravitreal injection of vascular endothelial growth factor (VEGF) Trap-Eye, a fusion protein of binding domains from human VEGF receptors 1 and 2 with human immunoglobulin-G Fc that binds VEGF family members, in patients with neovascular age-related macular degeneration (AMD). DESIGN: Dose-escalation, multicenter, interventional clinical trial. PARTICIPANTS: Twenty-one patients (13 female, 8 male) with neovascular AMD (NVAMD) and lesions or=50% active choroidal neovascularization (CNV) with best-corrected visual acuity (BCVA) or=3 lines and 3 patients requiring no adjunctive treatment of any type for 12 weeks. Some showed elimination of fluorescein leakage and reduction in area of CNV. CONCLUSIONS: Intravitreal injection of up to 4 mg of VEGF Trap-Eye in patients with NVAMD was well tolerated with no evidence of ocular inflammation. Although the number of patients in each cohort was small, there was evidence of bioactivity, because several patients, especially those receiving 2 or 4 mg of VEGF Trap-Eye, showed substantial improvement in BCVA associated with reductions in foveal thickness. Phase III trials to investigate the efficacy of intraocular VEGF Trap-Eye in patients with NVAMD are under way.

Full Text

Duke Authors

Cited Authors

  • Nguyen, QD; Shah, SM; Browning, DJ; Hudson, H; Sonkin, P; Hariprasad, SM; Kaiser, P; Slakter, JS; Haller, J; Do, DV; Mieler, WF; Chu, K; Yang, K; Ingerman, A; Vitti, RL; Berliner, AJ; Cedarbaum, JM; Campochiaro, PA

Published Date

  • November 2009

Published In

Volume / Issue

  • 116 / 11

Start / End Page

  • 2141 - 8.e1

PubMed ID

  • 19700196

Pubmed Central ID

  • 19700196

Electronic International Standard Serial Number (EISSN)

  • 1549-4713

Digital Object Identifier (DOI)

  • 10.1016/j.ophtha.2009.04.030

Language

  • eng

Conference Location

  • United States