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

Phase 2

Completed

• Conditions: Age-Related Macular Degeneration; Choroidal Neovascularization
• Interventions: Drug: Adalimumab

• Registration Number: NCT01136252
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-16
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adalimumab	Adalimumab	-

Primary Outcome Measures

Name	Time	Method
Patients proportion with electroretinogram alterations	6 months

Secondary Outcome Measures

Name	Time	Method
Changes in retinal thickness measured by ocular coherence tomography	once a month to 6 months
Changes in best corrected visual acuity	once a month to 6 months
Incidence of adverse events	until 6 months

Trial Locations

Locations (1)

Servicio de Oftalmologia. Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain