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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 20, 2014