Study for Recalcitrant Age Related Macular Degeneration
Part of paid clinical trials in Houston, Texas.
- Sponsor
- David M. Brown, M.D.
- Study ID
- NCT01543568
- Phase
- PHASE4
- Status
- Completed
Conditions
- Age Related Macular Degeneration
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- aflibercept 2.0 mg — DRUGIntravitreal aflibercept injection 2.0 mg
Study Details
50 Patients with recalcitrant exudative age-related macular degeneration with a history of retinal or subretinal fluid after multiple intravitreal injections with ranibizumab 0.5mg and subsequently treated with ranibizumab 2.0mg, who are incomplete responders to 2.0mg of ranibizumab.
Key Dates
- Start date
- Feb 29, 2012
- Status verified
- Nov 2016
- Primary completion
- Oct 31, 2014
- Completion
- Oct 31, 2014
Study Design
- Enrollment
- 46 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: 2.0 mg intravitreal Afliberceptopen label, Subjects seen monthly \& given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)
Primary Outcome Measure
The Number of Patients With no Fluid on OCT [ Time Frame: 6 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Retina Consultants of Houston | Houston | Texas | 77030 | - |
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