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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Rafic Hariri University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
American University of Beirut Medical Center
Information provided by:
Rafic Hariri University Hospital
ClinicalTrials.gov Identifier:
NCT00855608
First received: March 2, 2009
Last updated: July 20, 2011
Last verified: September 2009
  Purpose

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 Intervention Phase
Uveitis
Diabetic Retinopathy
Choroidal Neovascularization
Drug: adalimumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rafic Hariri University Hospital:

Primary Outcome Measures:
  • The main outcome measure will be visual acuity improvement (3 lines) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • central foveal thickness and angiographic lesion size [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   17 Years to 88 Years
Genders Eligible for Study:   Both
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
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: NCT00855608

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

Locations
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
Principal Investigator: ahmad m mansour, md RHUH
  More Information

Publications:
Responsible Party: Professor Ahmad Mansour, RHUH
ClinicalTrials.gov Identifier: NCT00855608     History of Changes
Other Study ID Numbers: RHUH
Study First Received: March 2, 2009
Last Updated: July 20, 2011
Health Authority: Lebanon: Institutional Review Board

Keywords provided by Rafic Hariri University Hospital:
choroidal neovascularization
diabetic retinopathy
uveitis
refractory cases of uveitis

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Uveitis
Chorioretinitis
Neovascularization, Pathologic
Choroidal Neovascularization
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Uveal Diseases
Retinitis
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis
Metaplasia
Pathologic Processes
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 22, 2014