NCT00527423

Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD

A Randomized, Single-Masked , Long-Term, Safety and Tolerability Study of Intravitreal VEGF Trap-Eye in Subjects With Neovascular Age-related Macular Degeneration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.

Detailed description

Randomized, Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatment.Long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the effect of VEGF Trap-Eye on best corrected visual acuity (BCVA).

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	VEGF Trap Eye	Intravitreal injection

Timeline

• Start date: 2007-08-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2007-09-10
• Last updated: 2013-06-12
• Results posted: 2013-06-12

Locations

33 sites across 1 country: United States