Prophylactic Anecortave Acetate in Patients With a Retisert Implant

NCT ID: NCT00570479

Last Updated: 2012-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2010-03-31

Brief 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.

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

Conditions

Uveitis, Posterior; Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

50 mgs of anecortave acetate (0.5 ml of a 10% suspension)

Group Type: ACTIVE_COMPARATOR

anecortave acetate

Intervention Type: DRUG

Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection

2

Patients will receive 30 mgs of anecortave acetate (0.5 ml of a 6% suspension)

Group Type: ACTIVE_COMPARATOR

anecortave acetate

Intervention Type: DRUG

Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection

3

Patients will receive 24 mgs of anecortave acetate (0.4 ml of a 6% suspension)

Group Type: ACTIVE_COMPARATOR

anecortave acetate

Intervention Type: DRUG

Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection

4

Patients will receive 12 mgs of anecortave acetate (0.2 ml of a 6% suspension)

Group Type: ACTIVE_COMPARATOR

anecortave acetate

Intervention Type: DRUG

Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection

Interventions

anecortave acetate

Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• 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 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Texas Retina Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David G Callanan, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Retina Associates

Locations

Texas Retina Associates

Arlington, Texas, United States

Countries

United States

Other Identifiers

Texas Retina DC-02

Identifier Type: -

Identifier Source: org_study_id