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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