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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Macular Degeneration

Treatments: Drug: VEGF Trap Eye

Study type: Interventional

Funder types: Industry

Identifiers

NCT00527423

VGFT-OD-0702

Details and patient eligibility

About

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.

Full 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).

Enrollment: 157 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prior participation in VEGF Trap-Eye Phase I and II studies

Exclusion criteria

• Any ocular or systemic adverse events that would preclude participation
• Presence of any condition that would jeopardize subject's participation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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157 participants in 1 patient group

Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)

Experimental group

Treatment:

Drug: VEGF Trap Eye