Prophylactic Anecortave Acetate in Patients With a Retisert Implant - Full Text View

Purpose

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.

Condition	Intervention	Phase
Uveitis, Posterior Glaucoma	Drug: anecortave acetate	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Prevention of Steroid-induced Glaucoma Using Anecortave Acetate

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

Further study details as provided by Texas Retina Associates:

Primary Outcome Measures:

Percentage of patients requiring glaucoma filtering surgery [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percentage of patients requiring topical glaucoma medication [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment:	12
Study Start Date:	September 2006
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility

Ages Eligible for Study:	10 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570479

Locations

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

Sponsors and Collaborators

Texas Retina Associates

Alcon Laboratories

Investigators

Principal Investigator:

David G Callanan, MD

Texas Retina Associates

More Information

No publications provided

Responsible Party:	Texas Retina Associates
ClinicalTrials.gov Identifier:	NCT00570479 History of Changes
Other Study ID Numbers:	Texas Retina DC-02
Study First Received:	December 9, 2007
Last Updated:	June 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Texas Retina Associates:

Retisert
Uveitis
glaucoma

Additional relevant MeSH terms:

Glaucoma
Uveitis
Chorioretinitis
Uveitis, Posterior
Ocular Hypertension
Eye Diseases

Uveal Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Panuveitis

ClinicalTrials.gov processed this record on May 16, 2013