Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Regeneron Pharmaceuticals
- Study ID
- NCT01722045
- Phase
- PHASE4
- Status
- Completed
Conditions
- Age - Related Macular Degeneration (AMD)
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
Study Details
This is a phase 4, open-label, single arm, multicenter, clinical study in patients with neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to provide clinical information from the first year in the trial evaluating the adverse effects, if any, on the corneal endothelium following administration of IAI.
Key Dates
- Start date
- Nov 30, 2012
- Status verified
- Nov 2017
- Primary completion
- Sep 30, 2015
- Completion
- Sep 30, 2015
Study Design
- Enrollment
- 154 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Open label IAI
Primary Outcome Measure
Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline to Week 100 ]
Locations (49)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Phoenix | Arizona | - | - |
| - | Tucson | Arizona | - | - |
| - | Beverly Hills | California | - | - |
| - | Oakland | California | - | - |
| - | Palm Desert | California | - | - |
| - | Sacramento | California | - | - |
| - | Santa Ana | California | - | - |
| - | Westlake Village | California | - | - |
| - | Colorado Springs | Colorado | - | - |
| - | Golden | Colorado | - | - |
| - | Boynton Beach | Florida | - | - |
| - | Fort Lauderdale | Florida | - | - |
| - | Fort Myers | Florida | - | - |
| - | Pensacola | Florida | - | - |
| - | Plantation | Florida | - | - |
| - | Tampa | Florida | - | - |
| - | Winter Haven | Florida | - | - |
| - | Augusta | Georgia | - | - |
| - | Oak Park | Illinois | - | - |
| - | New Albany | Indiana | - | - |
| - | Wichita | Kansas | - | - |
| - | Lexington | Kentucky | - | - |
| - | Boston | Massachusetts | - | - |
| - | Worcester | Massachusetts | - | - |
| - | Jackson | Michigan | - | - |
| - | Lincoln | Nebraska | - | - |
| - | Las Vegas | Nevada | - | - |
| - | Portsmouth | New Hampshire | - | - |
| - | Bloomfield | New Jersey | - | - |
| - | Lawrenceville | New Jersey | - | - |
| - | Northfield | New Jersey | - | - |
| - | Teaneck | New Jersey | - | - |
| - | Rochester | New York | - | - |
| - | Asheville | North Carolina | - | - |
| - | Oklahoma City | Oklahoma | - | - |
| - | Portland | Oregon | - | - |
| - | Salem | Oregon | - | - |
| - | Kingston | Pennsylvania | - | - |
| - | Pittsburgh | Pennsylvania | - | - |
| - | Florence | South Carolina | - | - |
| - | Ladson | South Carolina | - | - |
| - | West Columbia | South Carolina | - | - |
| - | Rapid City | South Dakota | - | - |
| - | Nashville | Tennessee | - | - |
| - | Arlington | Texas | - | - |
| - | Fort Worth | Texas | - | - |
| - | Houston | Texas | - | - |
| - | San Antonio | Texas | - | - |
| - | Seattle | Washington | - | - |
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