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Sponsors and Collaborators: |
Rafic Hariri University Hospital American University of Beirut Medical Center |
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Information provided by: | Rafic Hariri University Hospital |
ClinicalTrials.gov Identifier: | NCT00855608 |
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 |
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Uveitis Diabetic Retinopathy Choroidal Neovascularization |
Drug: adalimumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Safety and Tolerability of Intravitreal Adalimumab in Patients With Refractory Diabetic Macular Retinopathy or Choroidal Neovascularization or Uveitis: A Pilot Study |
Estimated Enrollment: | 15 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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adalimumab arm: Experimental
intravitreal mode of delivery
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Drug: adalimumab
intravitreal adalimumab injection 0.03 ml in volume (1.5mg) one dose to one eye
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Ages Eligible for Study: | 17 Years to 88 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: ahmad m mansour, md | 9611374625 | dr.ahmad@cyberia.net.lb |
Contact: george Mollayess, md | 961350000 ext 5750 | gm23@aub.edu.lb |
Lebanon, South Beirut | |
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 |
Principal Investigator: | ahmad m mansour, md | RHUH |
Responsible Party: | RHUH ( Professor Ahmad Mansour ) |
Study ID Numbers: | RHUH |
Study First Received: | March 2, 2009 |
Last Updated: | March 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00855608 History of Changes |
Health Authority: | Lebanon: Institutional Review Board |
choroidal neovascularization diabetic retinopathy uveitis refractory cases of uveitis |
Anti-Inflammatory Agents Eye Diseases Choroid Diseases Vascular Diseases Diabetes Mellitus Endocrine System Diseases Adalimumab Choroidal Neovascularization Diabetic Angiopathies |
Diabetic Retinopathy Uveitis Metaplasia Endocrinopathy Neovascularization, Pathologic Antirheumatic Agents Retinal Diseases Diabetes Complications |
Anti-Inflammatory Agents Uveal Diseases Eye Diseases Choroid Diseases Vascular Diseases Diabetes Mellitus Endocrine System Diseases Adalimumab Pharmacologic Actions Choroidal Neovascularization Diabetic Angiopathies |
Diabetic Retinopathy Pathologic Processes Uveitis Therapeutic Uses Metaplasia Cardiovascular Diseases Neovascularization, Pathologic Antirheumatic Agents Retinal Diseases Diabetes Complications |