Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Randomized, Single-Masked , Long-Term, Safety and Tolerability Study of Intravitreal VEGF Trap-Eye in Subjects With Neovascular Age-related Macular Degeneration|
- Number of Participants With Adverse Events (AE) [ Time Frame: Baseline of this study to Wk 152 ] [ Designated as safety issue: Yes ]Number of participants with AEs summarized by category
- Frequency (Number of Injections) [ Time Frame: Baseline of this study to Wk 152 ] [ Designated as safety issue: Yes ]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 [ Time Frame: Baseline of original study to Wk 156 ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2007|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|Experimental: Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)||
Drug: VEGF Trap Eye
Other Name: IVT
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).
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|Study Director:||Clinical Trial Management||Regeneron Pharmaceuticals|