Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome
Part of paid clinical trials in St Louis, Missouri.
- Sponsor
- Retina Research Institute, LLC
- Study ID
- NCT01578720
- Phase
- PHASE1
- Status
- Completed
Conditions
- Choroidal Neovascularization
- Presumed Ocular Histoplasmosis
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- EYLEA (Aflibercept) intravitreal injection — DRUGIntravitreal Injection once every 8 weeks with 3 initial monthly doses
Study Details
The purpose of this study is to assess the efficacy and safety of intravitreal injection of aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS).
Key Dates
- Start date
- Jun 30, 2012
- Status verified
- Aug 2018
- Primary completion
- Apr 30, 2014
- Completion
- Mar 31, 2015
Study Design
- Enrollment
- 5 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: IVT injection once every 8 weeks after 3 initial monthly dosesIntravitreal aflibercept injection 2.0mg dosed every 4 weeks (monthly)for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection every eight 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 greater than or equal to 5 letters from the previous visit.
Primary Outcome Measure
Safety [ Time Frame: 12 months ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Retina Institute | St Louis | Missouri | 63017 | - |
| The Retina Institute | St Louis | Missouri | 63128 | - |
| The Retina Institute | St Louis | Missouri | 63144 | - |
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