Status:
TERMINATED
Treatment of Rubeosis Iridis With Open-Label Anecortave Acetate Sterile Suspension ( 15 mg.).
Lead Sponsor:
Manhattan Eye, Ear & Throat Hospital
Collaborating Sponsors:
Alcon Research
Conditions:
Severe Diabetic Retinopathy
Central Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 o...
Detailed Description
Patients will receive an injection of 15 mg of Anecortave acetate behind the eye to be treated ("study eye"). They will be evaluated every six months to determine if their condition is stable or worse...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00211471
Start Date
March 1 2002
End Date
May 1 2007
Last Update
May 7 2007
Active Locations (1)
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1
Manhattan Eye, Ear & Throat Hospital
New York, New York, United States, 10021