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

Regeneron Pharmaceuticals157 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

157

Conditions

Macular Degeneration

Interventions

VEGF Trap EyeDRUG

Intravitreal injection

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (33)

Unnamed facility

Peoria, Arizona, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AE)

Number of participants with AEs summarized by category

Time frame: Baseline of this study to Wk 152

Secondary Outcomes

Frequency (Number of Injections)

Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).

Time frame: Baseline of this study to Wk 152

Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values

Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.

Time frame: Baseline of original study to Wk 156

Data from ClinicalTrials.gov

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