Prophylactic Anecortave Acetate in Patients With a Retisert Implant

Glaucoma Clinical Trial

Official title:

Prevention of Steroid-induced Glaucoma Using Anecortave Acetate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570479
• Other study ID #: Texas Retina DC-02
• Status: Completed
• Phase: Phase 1
• First received: December 9, 2007
• Last updated: June 3, 2012
• Start date: September 2006
• Est. completion date: March 2010

Study information

• Verified date: June 2012
• Source: Texas Retina Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glaucoma
• Uveitis, Posterior

Intervention

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

Locations

Country	Name	City	State
United States	Texas Retina Associates	Arlington	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Retina Associates	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients requiring glaucoma filtering surgery		3 years	Yes
Secondary	Percentage of patients requiring topical glaucoma medication		3 years	Yes