Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Study ID
- NCT01136252
- Phase
- PHASE2
- Status
- Completed
Conditions
- Age-Related Macular Degeneration
- Choroidal Neovascularization
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Adalimumab — DRUGIntravitreal adalimumab injection (0,1 ml= 50 mcg) in the eye of the included patients. Patients will be followed up every week for a total of 4 weeks, and after every month until 6 months. If it is necessary, repeat the injection every month, maximum three months
Study Details
Adalimumab is a humanized recombinant monoclonal antibody fragment targeted against tumor necrosis factor. This study will assess the safety and efficacy of intravitreal adalimumab administered in patients with choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with intravitreal ranibizumab.
Key Dates
- Start date
- May 31, 2010
- Status verified
- Mar 2012
- Primary completion
- Sep 30, 2011
- Completion
- Oct 31, 2011
Study Design
- Enrollment
- 5 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Adalimumab
Primary Outcome Measure
Patients proportion with electroretinogram alterations [ Time Frame: 6 months ]
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