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Intravitreal Adalimumab in Refractory Diabetic Retinopathy, Choroidal Neovascularization or Uveitis: A Pilot Study (ADA01)

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ClinicalTrials.gov Identifier: NCT00855608
Recruitment Status : Unknown
Verified September 2009 by Rafic Hariri University Hospital.
Recruitment status was:  Recruiting
First Posted : March 4, 2009
Last Update Posted : July 22, 2011
Sponsor:
Collaborator:
American University of Beirut Medical Center
Information provided by:
Rafic Hariri University Hospital

Study Description
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Brief Summary:
Direct intravitreal administration of medication is the preferred method of treatment for uveitis and retinal vascular disorders. The eye is a self contained organ relatively isolated from the systemic circulation by the tight blood retinal barrier. Effective intraocular drug levels can be achieved with a much smaller amount of medication if injected intravitreally and this also results in minimal systemic exposure to the patient. Preliminary studies have shown that adalimumab may have a positive role in the management of uveitis in humans and can be an effective treatment intravitreally in animal models. No data has been published yet on intravitreal use of adalimumab in human subjects.

Condition or disease Intervention/treatment Phase
Uveitis Diabetic Retinopathy Choroidal Neovascularization Drug: adalimumab Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Tolerability of Intravitreal Adalimumab in Patients With Refractory Diabetic Macular Retinopathy or Choroidal Neovascularization or Uveitis: A Pilot Study
Study Start Date : March 2009
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: adalimumab arm
intravitreal mode of delivery
 Drug: adalimumab
intravitreal adalimumab injection 0.03 ml in volume (1.5mg) one dose to one eye
Other Name: Humira


Outcome Measures
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Primary Outcome Measures :
  1. The main outcome measure will be visual acuity improvement (3 lines) [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. central foveal thickness and angiographic lesion size [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   17 Years to 88 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 17 years
  • Patients with active choroidal neovascularization, diabetic retinopathy, or uveitis in the study eye which did not improve with conventional therapy
  • Best corrected visual acuity of 20/70 or less.

Exclusion Criteria:

  • Are participating in another clinical study requiring follow up examinations
  • Have received any other experimental drug within 12 weeks prior to enrollment
  • Are unwilling or unable to follow or comply with all study-related procedures
  • Inability to obtain photographs, fluorescein angiography, or optical coherence tomography to document CNV, e.g. due to media opacity, allergy to fluorescein dye or lack of venous access
  • Aphakia or pseudophakia with the absence of posterior capsule (unless it resulted from a yttrium aluminum garner [YAG]) posterior capsulotomy)
  • Within two months prior to screening, have had intraocular surgery (including cataract surgery) in the study eye
  • Within 1 month prior to screening had YAG laser in the study eye
  • Have had intravitreal anti VEGF or intravitreal steroids in the last 6 weeks
  • Have had previous pars plana vitrectomy in the study eye
  • Are pregnant or are trying to become pregnant
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855608


Contacts
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Contact: ahmad m mansour, md 9611374625 dr.ahmad@cyberia.net.lb
Contact: george Mollayess, md 961350000 ext 5750 gm23@aub.edu.lb

Locations
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Lebanon
Rafic Hariri University Hospital Recruiting
Beirut, South Beirut, Lebanon, 1136044
Contact: ahmad m mansour, md    9611374625    dr.ahmad@cyberia.net.lb   
Contact: george mollayes, md    01350000 ext 5750    gm23@aub.edu.lb   
Principal Investigator: ahmad m mansour, md         
Sponsors and Collaborators
Rafic Hariri University Hospital
American University of Beirut Medical Center
Investigators
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Principal Investigator: ahmad m mansour, md RHUH
More Information
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Publications of Results:

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Responsible Party: Professor Ahmad Mansour, RHUH
ClinicalTrials.gov Identifier: NCT00855608     History of Changes
Other Study ID Numbers: RHUH
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: September 2009
Keywords provided by Rafic Hariri University Hospital:
choroidal neovascularization
diabetic retinopathy
uveitis
refractory cases of uveitis
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Uveitis
Choroidal Neovascularization
Neovascularization, Pathologic
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
 Diabetes Mellitus
Endocrine System Diseases
Uveal Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents