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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Age-Related Macular Degeneration, Choroidal Neovascularization
Both
Age-Related Macular Degeneration, Choroidal Neovascularization
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Patients proportion with electroretinogram alterations
Outcome Time Frame:
6 months
Safety Issue:
Yes
Principal Investigator
Miguel A Zapata, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hospital Vall d'Hebron
Authority:
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study ID:
ZAPA-01/EudraCT 2009-017429-21
NCT ID:
NCT01136252
Start Date:
May 2010
Completion Date:
October 2011
Related Keywords:
- Age-Related Macular Degeneration
- Choroidal Neovascularization
- Macular Degeneration
- Neovascularization, Pathologic
- Choroidal Neovascularization
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