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

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 |

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 |
- The main outcome measure will be visual acuity improvement (3 lines) [ Time Frame: 6 weeks ]
- central foveal thickness and angiographic lesion size [ Time Frame: 6 weeks ]

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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 |
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

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
Contact: ahmad m mansour, md | 9611374625 | dr.ahmad@cyberia.net.lb | |
Contact: george Mollayess, md | 961350000 ext 5750 | gm23@aub.edu.lb |
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 |
Principal Investigator: | ahmad m mansour, md | RHUH |
Publications of Results:
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 |
choroidal neovascularization diabetic retinopathy uveitis refractory cases of uveitis |
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 |