Primary endpoint results of a phase II study of vascular endothelial growth factor trap-eye in wet age-related macular degeneration
Ophthalmology, 2011•Elsevier
Objective To evaluate the biologic effects and safety of vascular endothelial growth factor
(VEGF) Trap-Eye during a 12-week fixed-dosing period in patients with neovascular (wet)
age-related macular degeneration (AMD). Design Multicenter, prospective, randomized,
double-masked clinical trial with initial 12-week fixed dosing period. Data were analyzed to
week 16. Participants We included 159 patients with subfoveal choroidal neovascularization
secondary to wet AMD. Methods Patients were randomized 1: 1: 1: 1: 1 to VEGF Trap-Eye …
(VEGF) Trap-Eye during a 12-week fixed-dosing period in patients with neovascular (wet)
age-related macular degeneration (AMD). Design Multicenter, prospective, randomized,
double-masked clinical trial with initial 12-week fixed dosing period. Data were analyzed to
week 16. Participants We included 159 patients with subfoveal choroidal neovascularization
secondary to wet AMD. Methods Patients were randomized 1: 1: 1: 1: 1 to VEGF Trap-Eye …
Objective
To evaluate the biologic effects and safety of vascular endothelial growth factor (VEGF) Trap-Eye during a 12-week fixed-dosing period in patients with neovascular (wet) age-related macular degeneration (AMD).
Design
Multicenter, prospective, randomized, double-masked clinical trial with initial 12-week fixed dosing period. Data were analyzed to week 16.
Participants
We included 159 patients with subfoveal choroidal neovascularization secondary to wet AMD.
Methods
Patients were randomized 1:1:1:1:1 to VEGF Trap-Eye during the fixed-dosing phase (day 1 to week 12): 0.5 or 2 mg every 4 weeks (0.5 mg q4wk, 2 mg q4wk) on day 1 and at weeks 4, 8, and 12; or 0.5, 2, or 4 mg every 12 weeks (0.5 mg q12wk, 2 mg q12wk, or 4 mg q12wk) on day 1 and at week 12.
Main Outcome Measures
The primary endpoint was change from baseline in central retinal/lesion thickness (CR/LT) at week 12; secondary outcomes included change in best-corrected visual acuity (BCVA), proportion of patients with a gain of ≥15 letters, proportion of patients with a loss of >15 letters, and safety.
Results
At week 12, treatment with VEGF Trap-Eye resulted in a significant mean decrease in CR/LT of 119 μm from baseline in all groups combined (P<0.0001). The reduction in CR/LT with the 2 mg q4wk and 0.5mg q4wk regimens was significantly greater than each of the quarterly dosing regimens. The BCVA increased significantly by a mean of 5.7 letters at 12 weeks in the combined group (P<0.0001), with the greatest mean gain of >8 letters in the monthly dosing groups. At 8 weeks, BCVA improvements were similar with 2 mg q4wk and 2 mg q12wk dosing. After the last required dose at week 12, CR/LT and visual acuity were maintained or further improved at week 16 in all treatment groups. Ocular adverse events were mild and consistent with safety profiles reported for other intraocular anti-VEGF treatments.
Conclusions
Repeated monthly intravitreal dosing of VEGF Trap-Eye over 12 weeks demonstrated significant reductions in retinal thickness and improvements in visual acuity, and was well-tolerated in patients with neovascular AMD.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found after the references.
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