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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01136252
First received: June 2, 2010
Last updated: March 16, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Age-Related Macular Degeneration
Choroidal Neovascularization
 Drug: Adalimumab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Patients proportion with electroretinogram alterations [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in retinal thickness measured by ocular coherence tomography [ Time Frame: once a month to 6 months ] [ Designated as safety issue: No ]
  • Changes in best corrected visual acuity [ Time Frame: once a month to 6 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: until 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: May 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab 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
Other Name: Humira®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136252

Locations
Spain
Servicio de Oftalmologia. Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Study Chair: Miguel A Zapata, MD Hospital Vall d'Hebron
  More Information

No publications provided

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01136252     History of Changes
Other Study ID Numbers: ZAPA-01/EudraCT 2009-017429-21, 2009-017429-21
Study First Received: June 2, 2010
Last Updated: March 16, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
 Choroid Diseases
Uveal Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013