Treatment of Rubeosis Iridis With Open-Label Anecortave Acetate Sterile Suspension ( 15 mg.).

Stopped early · Phase 2

Conditions studied: Severe Diabetic Retinopathy, Central Retinal Vein Occlusion, Chronic Inflammation, Infectious Diseases

In brief

To provide use of Anecortave Acetate Sterile Suspension of 15mg for a series of five patients with rubeosis iridis. Rubeosis iridis refers to neovascularization of the iris. It is caused by a number of conditions which include, but are not limited to severe diabetic retinopathy, central retinal vein occlusion, chronic inflammation, and infection. Anecortave acetate is an angiostatic, experimental drug that is being tested to prevent the growth of blood vessels under the retina in patients with age-related macular degeneration (AMD). Therefore, it is logical to apply the usage of Anecortave to patient's with rubeosis iridis in order to reduce the neovascularization stimulus and cause the regression of the abnormal iris vessels.

Key facts

Study ID

NCT00211471

Run by

Manhattan Eye, Ear & Throat Hospital

People needed

0

Starts

2002-03-01

Expected to finish

2007-05-01

Last updated by the study team

2007-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of rubeosis iridis in patients with retinal ischemia.
• Patients must be 18 years of age or older to receive treatment.
• Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart.
• Visual acuity of 20/800 or better Fellow Eye on the ETDRS visual acuity chart.

You may not qualify if…

• Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
• Patients who have undergone intraocular surgery within last 2 months.
• Patient participating in any other investigational drug study.
• Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
• Inability to obtain photographs to document CNV (including difficulty with venous access.
• Patient with significant liver disease or uremia.
• Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
• Patient has a history of any medical condition which would preclude scheduled visits or completion of study.
• Patient has had insertion of scleral buckle in the study eye.
• Patient has received radiation treatment.
• Patient is pregnant or nursing.
• Patient is on intravenous or subcutaneous anticoagulant therapy, or is on oral anticoagulant therapy (with the exception of aspirin and antiplatelet therapy) and cannot take a 5-day interruption in therapy prior to each depot or sham administration.
• Patient has evidence of scleral thinning seen at the time of external eye exam or at the time of depot or sham administration.

Where it is running

• Manhattan Eye, Ear & Throat Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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