Prophylactic Anecortave Acetate in Patients With a Retisert Implant

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Retisert implant is an effective therapy for controlling inflammation in patients with non-infectious posterior uveitis. One of the major complications of this device is the development of elevated intraocular pressure (IOP) following implantation in 60% of patients. Glaucoma filtering is required in over 30% of patients at 2 years. Anecortave acetate (AA) has been shown to reduce steroid induced elevated IOP. The purpose of this study was to evaluate the ability of prophylactic anterior juxtascleral depot administration of AA to prevent this Retisert induced elevated IOP.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Texas Retina Associates
• Collaborator: Alcon Research
• Treatments: Anecortave

Criteria

Inclusion Criteria:

Approximately 24 patients with recent implantation of the Retisert implant who meet the inclusion/exclusion criteria defined below will be enrolled in the study. They will be identified from the current and future patients of the clinical practices.

• Patients must be willing to sign an informed consent form, able to make the required study visits, and able to follow instructions.

• Patient must be at least 12 years of age.

• Implantation of a Retisert implant in the last 12 weeks.

Exclusion Criteria:

• Patient has history of any medical condition which would preclude scheduled study visits or completion of the study (i.e., unstable cardiovascular disease)

• Patient has insertion of a scleral buckle in the study eye.

• Patient has known medical history of allergy or sensitivity to the steroid family of drugs.

• Patient is on anticoagulant therapy, with the exception of aspirin and antiplatelet therapy. Patient has a medical history of a bleeding disorder.

• Patient has clinical evidence of scleral thinning.