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

Study Overview
=================
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).

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

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: VEGF Trap Eye


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)<br> | Drug: VEGF Trap Eye<br>* Intravitreal injection<br>* Other names: IVT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AE) | Number of participants with AEs summarized by category | Baseline of this study to Wk 152 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency (Number of Injections) | Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment). | 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. | Baseline of original study to Wk 156 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VEGF Trap-Eye, Macular Degeneration, AMD, Neovascular Age-Related Macular Degeneration