Prophylactic Anecortave Acetate in Patients With a Retisert Implant

Prevention of Steroid-induced Glaucoma Using Anecortave Acetate

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Uveitis, Posterior
• Intervention / Treatment: Drug: anecortave acetate

Detailed Description

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 months.

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:

Randomization: Yes

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Retina Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; 50 mgs of anecortave acetate (0.5 ml of a 10% suspension)	Drug: anecortave acetate; Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection
Active Comparator: 2; Patients will receive 30 mgs of anecortave acetate (0.5 ml of a 6% suspension)	Drug: anecortave acetate; Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection
Active Comparator: 3; Patients will receive 24 mgs of anecortave acetate (0.4 ml of a 6% suspension)	Drug: anecortave acetate; Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection
Active Comparator: 4; Patients will receive 12 mgs of anecortave acetate (0.2 ml of a 6% suspension)	Drug: anecortave acetate; Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients requiring glaucoma filtering surgery	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients requiring topical glaucoma medication	3 years

Collaborators and Investigators

• Sponsor: Texas Retina Associates
• Collaborators: Alcon Research
• Investigators: Principal Investigator: David G Callanan, MD, Texas Retina Associates

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: December 9, 2007
• First Submitted That Met QC Criteria: December 10, 2007
• First Posted (Estimate): December 11, 2007

Study Record Updates

• Last Update Posted (Estimate): June 5, 2012
• Last Update Submitted That Met QC Criteria: June 3, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Uveitis; glaucoma; Retisert
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Panuveitis; Uveal Diseases; Glaucoma; Uveitis; Uveitis, Posterior; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anecortave
• Other Study ID Numbers: Texas Retina DC-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No