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

Vall d'Hebron University Hospital (HUVH)

Status and phase: Completed; Phase 2

Conditions: Choroidal Neovascularization; Age-Related Macular Degeneration

Treatments: Drug: Adalimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01136252

2009-017429-21 (EudraCT Number)

ZAPA-01/EudraCT 2009-017429-21

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Adalimumab

Experimental group

Treatment:

Drug: Adalimumab