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

Phase 2

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: VEGF Trap Eye

• Registration Number: NCT00527423
• Lead Sponsor: Regeneron Pharmaceuticals

Brief 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).

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-09-06
• Study First Submitted QC: 2007-09-07
• Study First Posted: 2007-09-10
• Disposition First Submitted: 2011-04-25
• Disposition First Submitted QC: 2011-04-25
• Disposition First Posted: 2011-04-29
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2012-11-02
• Status Verified: 2013-06
• Results First Submitted QC: 2013-06-10
• Last Update Submitted: 2013-06-10
• Results First Posted: 2013-06-12
• Last Update Posted: 2013-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)	VEGF Trap Eye	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AE)	Baseline of this study to Wk 152	Number of participants with AEs summarized by category

Secondary Outcome Measures

Name	Time	Method
Frequency (Number of Injections)	Baseline of this study to Wk 152	Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).
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	Baseline of original study to Wk 156	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.