Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Overview
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.
Full Title of Study: “Open-label Clinical Trial to Evaluate Safety and Efficacy of Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Non-responders to the Conventional Treatment With Ranibizumab”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 2011
Interventions
- Drug: Adalimumab
- Intravitreal 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
Arms, Groups and Cohorts
- Experimental: Adalimumab
Clinical Trial Outcome Measures
Primary Measures
- Patients proportion with electroretinogram alterations
- Time Frame: 6 months
Secondary Measures
- Changes in retinal thickness measured by ocular coherence tomography
- Time Frame: once a month to 6 months
- Changes in best corrected visual acuity
- Time Frame: once a month to 6 months
- Incidence of adverse events
- Time Frame: until 6 months
Participating in This Clinical Trial
Inclusion Criteria
- Choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with ranibizumab (active choroidal neovascularization after loading phase of one injection per month for three consecutive months, followed by a maintenance phase with 5 injections in the last 12 months or 3 injections in the last 6 months Exclusion Criteria:
- Only one functional eye – Hypersensitivity to adalimumab or any component of the formulation – Previous systemic treatment with adalimumab – Cancer – Life expectancy <1 year
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Hospital Universitari Vall d’Hebron Research Institute
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Miguel A Zapata, MD, Study Chair, Hospital Vall d’Hebron
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