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Sponsors and Collaborators: |
Texas Retina Associates Alcon Laboratories |
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Information provided by: | Texas Retina Associates |
ClinicalTrials.gov Identifier: | NCT00570479 |
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 |
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Uveitis, Posterior Glaucoma |
Drug: anecortave acetate |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Prevention of Steroid-Induced Glaucoma Using Anecortave Acetate |
Estimated Enrollment: | 24 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | December 2009 |
Arms | Assigned Interventions |
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1: Active Comparator
50 mgs of anecortave acetate (0.5 ml of a 10% suspension)
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Drug: anecortave acetate
Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection
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2: Active Comparator
Patients will receive 30 mgs of anecortave acetate (0.5 ml of a 6% suspension)
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Drug: anecortave acetate
Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection
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3: Active Comparator
Patients will receive 24 mgs of anecortave acetate (0.4 ml of a 6% suspension)
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Drug: anecortave acetate
Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection
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4: Active Comparator
Patients will receive 12 mgs of anecortave acetate (0.2 ml of a 6% suspension)
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Drug: anecortave acetate
Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection
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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
Ages Eligible for Study: | 10 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Exclusion Criteria:
United States, Texas | |
Texas Retina Associates | Recruiting |
Arlington, Texas, United States, 76012 | |
Contact: Patricia Bradley 817-261-9625 pbradley@texasretina.com | |
Contact: Jodi Creighton 817-261-9625 jcreighton@texasretina.com |
Principal Investigator: | David G Callanan, MD | Texas Retina Associates |
Responsible Party: | Texas Retina Associates ( David Callanan, MD ) |
Study ID Numbers: | Texas Retina DC-02 |
Study First Received: | December 9, 2007 |
Last Updated: | December 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00570479 |
Health Authority: | United States: Food and Drug Administration |
Retisert Uveitis glaucoma |
Panuveitis Fluocinolone Acetonide Uveitis, Posterior Uveitis |
Glaucoma Eye Diseases Hypertension Ocular Hypertension |
Uveal Diseases |