Status:
UNKNOWN
Intravitreal Adalimumab in Refractory Diabetic Retinopathy, Choroidal Neovascularization or Uveitis: A Pilot Study
Lead Sponsor:
Rafic Hariri University Hospital
Collaborating Sponsors:
American University of Beirut Medical Center
Conditions:
Uveitis
Diabetic Retinopathy
Eligibility:
All Genders
17-88 years
Phase:
PHASE1
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 systemi...
Detailed Description
Abstract Purpose: Our aim is study to determine the efficacy and safety of intravitreal adalimumab in patients with active vision threatening uveitis, diabetic macular edema (DME) and choroidal neovas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00855608
Start Date
March 1 2009
End Date
March 1 2013
Last Update
July 22 2011
Active Locations (1)
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1
Rafic Hariri University Hospital
Beirut, South Beirut, Lebanon, 1136044