A Phase 1 interventional study of anecortave acetate in Uveitis, Posterior and Glaucoma, sponsored by Texas Retina Associates. Completed at 1 site in United States. Open to participants aged 10 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-06-05.
Sponsored by Texas Retina Associates · Phase 1, Interventional, and Prevention
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.
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
61 studies on the registry are indexed under Uveitis, Posterior; 4 are open to participants now.
This study's enrollment of 12 is below the median of 37 across 45 interventional studies indexed under Uveitis, Posterior.
Browse Uveitis, Posterior studies →Texas Retina Associates is the lead sponsor of 5 studies on the registry; none are open to participants now.
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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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
50 mgs of anecortave acetate (0.5 ml of a 10% suspension)
Drug: anecortave acetate
Patients will receive 30 mgs of anecortave acetate (0.5 ml of a 6% suspension)
Drug: anecortave acetate
Patients will receive 24 mgs of anecortave acetate (0.4 ml of a 6% suspension)
Drug: anecortave acetate
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
Percentage of patients requiring glaucoma filtering surgery
Time frame: 3 years
Percentage of patients requiring topical glaucoma medication
Time frame: 3 years
The record gives a start of Sep 2006, a primary completion of Mar 2010 and a completion of Mar 2010. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Anecortave acetate
Texas Retina Associates