Overview

Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Treatments:
Adalimumab
Criteria
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