Intravitreal Infliximab for Diabetic Macular Edema (DME) and Choroidal Neovascularization (CNV)
NCT00695682 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2008-06-12
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 retinal disease and improving patients' vision.
Infliximab (Remicade) is a genetically engineered antibody against a molecule in the body called TNF-α. It neutralizes the effects of TNF-α by binding to it. Intravenous Infliximab has been used for inflammatory arthritic conditions and Crohn's disease since 1998. We do not know if infliximab injections into the eye are safe. We are performing this pilot study to determine if they can be safe.
Conditions
- Diabetic Retinopathy
- Macular Degeneration
Interventions
- DRUG
-
intravitreal injection of infliximab
All subjects will receive 0.5 mg/ 0.05 mL of infliximab by intravitreal injection at their first treatment visit or the 6 weeks visit if eligible for a repeat injection.
Sponsors & Collaborators
-
Retina Research Foundation
lead OTHER
Principal Investigators
-
Paul M Beer, MD · Retina Research Foundation
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2008-12-31
- Completion
- 2008-12-31
Countries
- United States
Study Locations
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