Intravitreal Infliximab for Diabetic Macular Edema (DME) and Choroidal Neovascularization (CNV) (ITVR)
|ClinicalTrials.gov Identifier: NCT00695682|
Recruitment Status : Unknown
Verified June 2008 by Retina Research Foundation.
Recruitment status was: Recruiting
First Posted : June 12, 2008
Last Update Posted : June 12, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy Macular Degeneration||Drug: intravitreal injection of infliximab||Phase 1|
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 administration carries the risk of systemic side effects, which in the case of infliximab can be severe, such as increased risk of infection, reactivation of tuberculosis or Hepatosplenic T-cell Lymphoma.
Direct intravitreal administration of medication is the preferred method of treatment for 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 Infliximab may have a positive role in the management of retinal vascular disorders in humans when administered intravenously, and can be an effective treatment intravitreally in animal models. No data has been published yet on intravitreal use of infliximab in human subjects.
We plan to study the safety and tolerability of intravitreal injections of infliximab in human subjects with refractory diabetic macular edema or choroidal neovascularization. Our infliximab dose will be 0.5mg/0.5ml, as it follows the reconstitution instructions in the Product Insert. This dosing will fall within the therapeutic dosing found within the animal study as it leads to the same vitreous concentration as the7.5 µg dose in group B rat eye study. (4)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Safety and Tolerability of Intravitreal Infliximab (Remicade) in Patients With Refractory Diabetic Macular Edema or Choroidal Neovascularization Secondary to Age Related Macular Degeneration- A Pilot Study|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||December 2008|
|Estimated Study Completion Date :||December 2008|
U.S. FDA Resources
Drug: intravitreal injection of infliximab
- This is a pilot study to study the safety and tolerability of intravitreal Infliximab in patients with refractory diabetic macular edema and choroidal neovascularization (CNV) [ Time Frame: 3 m ]
- (BCVA) [ Time Frame: 3m ]
- Standard Electroretinogram [ Time Frame: 3m ]
- OCT [ Time Frame: 3m ]
- Fluorescein angiography [ Time Frame: 3m ]
- Nidek Microperimetry [ Time Frame: 3m ]
- Incidence and severity of adverse events [ Time Frame: 3m ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695682
|United States, New York|
|SLingerlands, New York, United States, 12159|
|Contact: Paul Beer, MD 518-533-6550|
|Principal Investigator: Paul M Beer, MD|
|Principal Investigator:||Paul M Beer, MD||Retina Research Foundation|