Treat and Extend Therapy Study Using Intravitreal Aflibercept for Patients Exited From Protocol VGFT-OD 0910
Part of paid clinical trials in Augusta, Georgia.
- Sponsor
- Palmetto Retina Center, LLC
- Study ID
- NCT01961414
- Phase
- PHASE4
- Status
- Unknown
Conditions
- Exudative Age-related Macular Degeneration
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Aflibercept — DRUGPatients will receive Aflibercept 2.0mg intravitreal injection at all scheduled study visits
Study Details
The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of aflibercept 2.0mg injections inside the eye for treating patients with Wet Age-related Macular Degeneration.
Key Dates
- Start date
- Oct 31, 2013
- Status verified
- Oct 2015
- Primary completion
- Mar 31, 2016
- Completion
- Jul 31, 2016
Study Design
- Enrollment
- 45 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: AfliberceptAll patients will receive aflibercept 2.0mg intravitreal injection
Primary Outcome Measure
Portion of patients who maintain vision (loss of < or = 5 letters ETDRS BCVA) from baseline to Year 1. [ Time Frame: 1 Year ]
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Southeast Retina | Augusta | Georgia | 30909 | - |
| Eye Surgical Associates | Lincoln | Nebraska | 68506 | - |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | - |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | - |
| Retina Consultants Houston | Houston | Texas | 77030 | - |
| Rocky Mountain Retina | Salt Lake City | Utah | 84107 | - |