Diabetic Retinopathy Clinical Trial
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
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.
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)
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