Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD
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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.
Condition or disease
Drug: VEGF Trap Eye
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).
Number of Participants With Adverse Events (AE) [ Time Frame: Baseline of this study to Wk 152 ]
Number of participants with AEs summarized by category
Secondary Outcome Measures
Frequency (Number of Injections) [ Time Frame: 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 [ Time Frame: 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.
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Ages Eligible for Study:
50 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Prior participation in VEGF Trap-Eye Phase I and II studies
Any ocular or systemic adverse events that would preclude participation
Presence of any condition that would jeopardize subject's participation