Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
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
2 other identifiers
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 2, 2010
CompletedFirst Posted
Study publicly available on registry
June 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedMarch 19, 2012
March 1, 2012
1.3 years
June 2, 2010
March 16, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Patients proportion with electroretinogram alterations
6 months
Secondary Outcomes (3)
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
Study Arms (1)
Adalimumab
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- Only one functional eye
- Hypersensitivity to adalimumab or any component of the formulation
- Previous systemic treatment with adalimumab
- Cancer
- Life expectancy \<1 year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Servicio de Oftalmologia. Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Miguel A Zapata, MD
Hospital Vall d'Hebron
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2010
First Posted
June 3, 2010
Study Start
May 1, 2010
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
March 19, 2012
Record last verified: 2012-03