Back to resultsIntravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Primary Purpose
Age-Related Macular Degeneration, Choroidal Neovascularization
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration
Eligibility 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
Sites / Locations
- Servicio de Oftalmologia. Hospital Universitario Vall d'Hebron
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adalimumab
Arm Description
Outcomes
Primary Outcome Measures
Patients proportion with electroretinogram alterations
Secondary Outcome Measures
Changes in retinal thickness measured by ocular coherence tomography
Changes in best corrected visual acuity
Incidence of adverse events
Full Information
NCT ID
NCT01136252
First Posted
June 2, 2010
Last Updated
March 16, 2012
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01136252
Brief Title
Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration, Choroidal Neovascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adalimumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira®
Intervention Description
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
Primary Outcome Measure Information:
Title
Patients proportion with electroretinogram alterations
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in retinal thickness measured by ocular coherence tomography
Time Frame
once a month to 6 months
Title
Changes in best corrected visual acuity
Time Frame
once a month to 6 months
Title
Incidence of adverse events
Time Frame
until 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel A Zapata, MD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Study Chair
Facility Information:
Facility Name
Servicio de Oftalmologia. Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
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