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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title:

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 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.

Detailed Summary:

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. Following the injection of study medication, patients will not be required to come in to see the study physician. The investigator or study staff will call the patients on the day following injection to make sure there were no adverse effects to the injection. Patients will then come in for a Month 1 and a Month 3 follow-up visit. At the Month 3 follow-up visit, if patients are not showing stability or improvement, they may be offered either thermal laser or Photodynamic Therapy. They will remain in the study and remain eligible for a repeat injection of Anecortave Acetate at the Month 6 visit.

Patients will then been seen at Month 6 for a Re-treatment Evaluation Visit. If their condition is stable, they will be offered re-injection with the same study medication they received earlier. If Patients are not showing stability or improvement at the Month 6 visit, they may be offered thermal laser or Photodynamic Therapy in conjunction with the Anecortave Acetate injection.

Patients will then come back again for a Month 1 and a Month 3 visit and an Exit Visit, if necessary. If the patient's condition is worse, patients will be exited from this study and offered standard treatment.

Sponsor: Manhattan Eye, Ear & Throat Hospital

Current Primary Outcome: to investigate the use of anecortave acetate in radiation retinopathy [ Time Frame: 24 months ]

Original Primary Outcome:

Current Secondary Outcome: mean change of ETDRS VA from baseline to 24 monthe [ Time Frame: 2 years ]

Original Secondary Outcome:

Information By: Manhattan Eye, Ear & Throat Hospital

Dates:
Date Received: September 13, 2005
Date Started: April 2004
Date Completion:
Last Updated: June 20, 2007
Last Verified: June 2007