Status:
TERMINATED
Treatment of Radiation Retinopathy With Open-Label Anecortave Acetate Sterile Suspension (15 mg)
Lead Sponsor:
Manhattan Eye, Ear & Throat Hospital
Collaborating Sponsors:
Alcon Research
Conditions:
Eye Injuries
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Radiation retinopathy is a disease of the retina. It occurs in people who have received or been exposed to radiation near the eyes. The blood vessels are abnormal and may grow which lead to scarring a...
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 radiation retinopathy.
- Patients must be 18 years of age or older to receive treatment.
- Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
- Visual acuity of 20/800 or better in 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 the 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 choroidal neovascularization (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 on anticoagulant therapy with the exception of aspirin
- Patient is pregnant or nursing.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00211367
Start Date
April 1 2004
End Date
March 1 2007
Last Update
June 21 2007
Active Locations (1)
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1
Manhattan Eye, Ear & Throat Hospital
New York, New York, United States, 10021