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.
Test Article: Anecortave Acetate: 6% and 10% Sterile Suspension
Drug Study Dosage: Patients will receive an injection (0.5 mL, 0.4 mL, or 0.2 mL of the 6%
Anecortave Acetate suspension or 0.5 mL of the 10% suspension) of study medication every 4
Active Ingredients: Anecortave Acetate (AL-3789)
Route of Administration: Sub-Tenon injection
Objective(s): To evaluate the safety and efficacy of four dosages (50 mg, 30 mg, 24 mg, or
12 mg) of Anecortave Acetate (AA) for the prevention of steroid-induced intraocular pressure
(IOP) elevations caused by Retisert.
Study Population: Approximately 24 patients
Structure: Parallel Group Duration of Treatment: 3 years
Description: Observer-masked study of the safety and efficacy of Anecortave Acetate 6% or 10
% administered by a sub-Tenon injection. Up to 24 patients with recent implantation of a
Retisert implant will be given a sub-Tenon injection of either 0.5 mL, 0.4 mL, or 0.2 mL of
6% Anecortave Acetate Sterile suspension or 0.5 mL of the 10% suspension. Patients will
receive periodic evaluations and re-treatment every 4 months for as long as 3 years. The
end point will be an IOP which requires surgical intervention. An initial assessment of
efficacy will be made at 18 months. If any patient treated with a lower dose develops an
IOP of greater than 30mHg, then they are eligible to receive the 50 mg dose.
Multicenter: Yes Number of Centers: 1 Masking: Observer masked (IOP-reader)
Method of Patient Assignment:
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.
- 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
- 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.