Intravitreal Infliximab for Diabetic Macular Edema (DME) and Choroidal Neovascularization (CNV)

Status unconfirmed · Phase 1

Conditions studied: Diabetic Retinopathy, Macular Degeneration

In brief

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.

Key facts

Study ID

NCT00695682

Run by

Retina Research Foundation

People needed

4

Starts

2008-06-01

Expected to finish

2008-12-01

Last updated by the study team

2008-06-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Retina Consultants — Slingerlands, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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