Prophylactic Anecortave Acetate in Patients With a Retisert Implant

Status Completed

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.

Clinical Trial 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 ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00570479
Study type	Interventional
Source	Texas Retina Associates
Contact
Status	Completed
Phase	Phase 1
Start date	September 2006
Completion date	March 2010

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06000865` - Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE	N/A
Recruiting	`NCT06278597` - Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device	N/A
Active, not recruiting	`NCT04271709` - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)	N/A
Recruiting	`NCT03274024` - The Asia Primary Tube Versus Trab (TVT) Study	N/A
Completed	`NCT04552964` - Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma	N/A
Recruiting	`NCT01957267` - Functional and Structural Imaging for Glaucoma
Active, not recruiting	`NCT04624698` - iStent Inject New Enrollment Post-Approval Study	N/A
Completed	`NCT04020705` - The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma	N/A
Completed	`NCT03150160` - Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma	Phase 4
Not yet recruiting	`NCT05581498` - Glaucoma Exercise as Medicine Study (GEMS).	N/A
Recruiting	`NCT02921568` - Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes	N/A
Active, not recruiting	`NCT02901730` - Clinical Study of LPI With Different Laser Wavelengths	N/A
Completed	`NCT02955849` - A Trial of China Laser and Surgery Study Glaucoma in Rural China	Early Phase 1
Recruiting	`NCT02471105` - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml	Phase 4
Recruiting	`NCT02554214` - Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device	N/A
Active, not recruiting	`NCT02390284` - Stop Retinal Ganglion Cell Dysfunction Study	Phase 3
Completed	`NCT02653963` - Triamcinolone for Ahmed Glaucoma Valve	N/A
Completed	`NCT02628223` - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma	N/A
Completed	`NCT02520674` - Glaucoma Screening With Smartphone Ophthalmology	N/A
Completed	`NCT02390245` - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.