Status:
UNKNOWN
Intravitreal Infliximab for Diabetic Macular Edema (DME) and Choroidal Neovascularization (CNV)
Lead Sponsor:
Retina Research Foundation
Conditions:
Diabetic Retinopathy
Macular Degeneration
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Injections of medicine into the middle of the eye (intravitreal injections) are commonly used in a multitude of retinal diseases. We are looking for new treatments that may be beneficial in treating r...
Detailed Description
Intravenous Infliximab is currently used for the treatment of systemic inflammatory conditions and inflammatory disease of the eye with a relatively favorable safety profile. However, systemic adminis...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age \> 21 years
- Patients with active CNV secondary to AMD in the study eye which did not improve with conventional therapy
- Patients with refractory diabetic macular edema in the study eye which did not improve with conventional therapy
- BCVA 20/70 or less as measured on an ETDRS chart.
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
- Have a history of allergies to murine monoclonal antibodies, mice or mouse products.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00695682
Start Date
June 1 2008
End Date
December 1 2008
Last Update
June 12 2008
Active Locations (1)
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1
Retina Consultants
Slingerlands, New York, United States, 12159