Prophylactic Anecortave Acetate in Patients With a Retisert Implant

NCT00570479 | Completed Phase 1

• 1 other identifier: Texas Retina DC-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uveitis, Posterior; Glaucoma

Keywords

Retisert; Uveitis; glaucoma

Outcome Measures

Primary Outcomes (1)

• Percentage of patients requiring glaucoma filtering surgery

  3 years

Secondary Outcomes (1)

• Percentage of patients requiring topical glaucoma medication

  3 years

Study Arms (4)

1

ACTIVE COMPARATOR

50 mgs of anecortave acetate (0.5 ml of a 10% suspension)

Drug: anecortave acetate

2

ACTIVE COMPARATOR

Patients will receive 30 mgs of anecortave acetate (0.5 ml of a 6% suspension)

Drug: anecortave acetate

3

ACTIVE COMPARATOR

Patients will receive 24 mgs of anecortave acetate (0.4 ml of a 6% suspension)

Drug: anecortave acetate

4

ACTIVE COMPARATOR

Patients will receive 12 mgs of anecortave acetate (0.2 ml of a 6% suspension)

Drug: anecortave acetate

Interventions

anecortave acetate DRUG

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

1; 2; 3; 4

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Texas Retina Associates: lead
• Alcon Research: collaborator

Study Sites (1)

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

MeSH Terms

Conditions

Uveitis, Posterior; Glaucoma; Uveitis

Interventions

anecortave acetate

Condition Hierarchy (Ancestors)

Panuveitis; Uveal Diseases; Eye Diseases; Ocular Hypertension

Study Officials

• David G Callanan, MD

  Texas Retina Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2007
• First Posted: December 11, 2007
• Study Start: September 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

US (1)