Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results
Part of paid clinical trials in St Louis, Missouri.
- Sponsor
- Retina Research Institute, LLC
- Study ID
- NCT01657669
- Phase
- PHASE4
- Status
- Unknown
Conditions
- Age Related Macular Degeneration
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Intravitreal Aflibercept injection — DRUGIntravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection once every 8 weeks (2 months). Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on OCT and/or a decrease in visual acuity of 5 letters or more from the best previous visit.
Study Details
This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection administered in subject who have active choroidal neovascularization due to Age Related Macular Degeneration (AMD).
Key Dates
- Start date
- Oct 31, 2012
- Status verified
- Oct 2017
- Primary completion
- Nov 30, 2014
- Completion
- Dec 31, 2017
Study Design
- Enrollment
- 22 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Intravitreal Aflibercept injectionIntravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mg) via intravitreal injection once every 8 weeks (2 months).
Primary Outcome Measure
Resolution time of intraretinal cysts and sub retinal fluid on OCT [ Time Frame: 12 months ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Retina Institute | St Louis | Missouri | 63128 | - |
| The Retina Institute | St Louis | Missouri | 63141 | - |
| Valley Retina Institute | McAllen | Texas | 78503 | - |
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