Treatment of Radiation Retinopathy With Open-Label Anecortave Acetate Sterile Suspension (15 mg)

Stopped early · Phase 2

Conditions studied: Eye Injuries

In brief

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 and a loss of central vision. Currently, the treatment for radiation retinopathy is laser photocoagulation. This treatment has been found to have limited use in this type of condition. Compassionate use of anecortave acetate injection is being considered to prevent the growth of the blood vessels under the retina.

Key facts

Study ID

NCT00211367

Run by

Manhattan Eye, Ear & Throat Hospital

People needed

2

Starts

2004-04-01

Expected to finish

2007-03-01

Last updated by the study team

2007-06-21

Who can join

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

You may qualify if…

• 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.

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 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.

Where it is running

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

Full record on ClinicalTrials.gov

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