Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)
Part of paid clinical trials in Birmingham (2 Locations), Alabama.
- Sponsor
- Regeneron Pharmaceuticals
- Study ID
- NCT00964795
- Phase
- PHASE3
- Status
- Completed
Conditions
- Neovascular Age-related Macular Degeneration
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
Study Details
The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.
Key Dates
- Start date
- Dec 31, 2009
- Status verified
- Mar 2015
- Primary completion
- Aug 31, 2013
- Completion
- Aug 31, 2013
Study Design
- Enrollment
- 323 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Open-label Intravitreal Aflibercept InjectionOpen-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
Primary Outcome Measure
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD [ Time Frame: Baseline (day 1) through end of treatment (Week 180) ]
Locations (115)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Birmingham (2 Locations) | Alabama | - | - |
| - | Phoenix (2 Locations) | Arizona | - | - |
| - | Tucson (2 Locations) | Arizona | - | - |
| - | Arcadia | California | - | - |
| - | Beverly Hills | California | - | - |
| - | Campbell | California | - | - |
| - | Fresno | California | - | - |
| - | Fullerton | California | - | - |
| - | La Jolla | California | - | - |
| - | Loma Linda | California | - | - |
| - | Mountain View | California | - | - |
| - | Oakland | California | - | - |
| - | Orange | California | - | - |
| - | Palm Desert | California | - | - |
| - | Sacramento | California | - | - |
| - | San Mateo | California | - | - |
| - | Santa Ana | California | - | - |
| - | Torrance | California | - | - |
| - | Westlake Village | California | - | - |
| - | Yorba Linda | California | - | - |
| - | Colorado Springs | Colorado | - | - |
| - | Denver (2 Locations) | Colorado | - | - |
| - | Bridgeport | Connecticut | - | - |
| - | New Haven | Connecticut | - | - |
| - | New London | Connecticut | - | - |
| - | Altamonte Springs | Florida | - | - |
| - | Boynton Beach | Florida | - | - |
| - | Fort Myers (2 Locations) | Florida | - | - |
| - | Jacksonville | Florida | - | - |
| - | Miami | Florida | - | - |
| - | Orlando (2 Locations) | Florida | - | - |
| - | Oscala | Florida | - | - |
| - | Palm Beach Gardens | Florida | - | - |
| - | Pensacola | Florida | - | - |
| - | Stuart | Florida | - | - |
| - | Tampa | Florida | - | - |
| - | Winter Haven | Florida | - | - |
| - | Augusta | Georgia | - | - |
| - | ‘Aiea | Hawaii | - | - |
| - | Glenview | Illinois | - | - |
| - | Fort Wayne | Indiana | - | - |
| - | Indianapolis | Indiana | - | - |
| - | New Albany | Indiana | - | - |
| - | Iowa City | Iowa | - | - |
| - | Wichita | Kansas | - | - |
| - | Louisville | Kentucky | - | - |
| - | New Orleans | Louisiana | - | - |
| - | Bangor | Maine | - | - |
| - | Portland | Maine | - | - |
| - | Baltimore (3 Locations) | Maryland | - | - |
| - | Chevy Chase | Maryland | - | - |
| - | Hagerstown | Maryland | - | - |
| - | Boston (2 Locations) | Massachusetts | - | - |
| - | Peabody | Massachusetts | - | - |
| - | Ann Arbor | Michigan | - | - |
| - | Battle Creek | Michigan | - | - |
| - | Grand Rapids | Michigan | - | - |
| - | Jackson | Michigan | - | - |
| - | Southfield | Michigan | - | - |
| - | Minneapolis | Minnesota | - | - |
| - | Rochester | Minnesota | - | - |
| - | Florissant | Missouri | - | - |
| - | Kansas City | Missouri | - | - |
| - | Springfield | Missouri | - | - |
| - | St Louis | Missouri | - | - |
| - | Missoula | Montana | - | - |
| - | Lincoln | Nebraska | - | - |
| - | Las Vegas | Nevada | - | - |
| - | Portsmouth | New Hampshire | - | - |
| - | Lawrenceville | New Jersey | - | - |
| - | Northfield | New Jersey | - | - |
| - | Toms River | New Jersey | - | - |
| - | Albuquerque | New Mexico | - | - |
| - | Albany | New York | - | - |
| - | Brooklyn | New York | - | - |
| - | Lynbrook | New York | - | - |
| - | New York (6 Locations) | New York | - | - |
| - | Rochester (2 Locations) | New York | - | - |
| - | Slingerlands | New York | - | - |
| - | Syracuse | New York | - | - |
| - | Asheville | North Carolina | - | - |
| - | Charlotte | North Carolina | - | - |
| - | Raleigh | North Carolina | - | - |
| - | Winston-Salem | North Carolina | - | - |
| - | Cincinnati | Ohio | - | - |
| - | Cleveland | Ohio | - | - |
| - | Oklahoma City | Oklahoma | - | - |
| - | Ashland | Oregon | - | - |
| - | Portland (3 Locations) | Oregon | - | - |
| - | Salem | Oregon | - | - |
| - | Kingston | Pennsylvania | - | - |
| - | Philadelphia (3 Locations) | Pennsylvania | - | - |
| - | Pittsburgh (2 Locations) | Pennsylvania | - | - |
| - | West Mifflin | Pennsylvania | - | - |
| - | Columbia | South Carolina | - | - |
| - | Greenville | South Carolina | - | - |
| - | West Columbia | South Carolina | - | - |
| - | Rapid City | South Dakota | - | - |
| - | Nashville | Tennessee | - | - |
| - | Austin (3 Locations) | Texas | - | - |
| - | Dallas | Texas | - | - |
| - | Fort Worth (2 Locations) | Texas | - | - |
| - | Houston | Texas | - | - |
| - | McAllen | Texas | - | - |
| - | Odessa | Texas | - | - |
| - | San Antonio (2 Locations) | Texas | - | - |
| - | Tyler | Texas | - | - |
| - | Salt Lake City (2 Locations) | Utah | - | - |
| - | Burlington | Vermont | - | - |
| - | Charlottesville | Virginia | - | - |
| - | Fairfax | Virginia | - | - |
| - | Richmond | Virginia | - | - |
| - | Seattle | Washington | - | - |
| - | Madison (2 Locations) | Wisconsin | - | - |
| - | Milwaukee | Wisconsin | - | - |
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