An Evaluation of Efficacy and Safety of Posterior Juxtascleral Administrations of Anecortave Acetate for Depot Suspension (15 mg or 30 mg) versus Sham Administration in Patients (Enrolled in Study A” or Study B”) at Risk for Developing Sight-Threatening Choroidal Neovascularisation (CNV) Due to Exudative Age-Related Macular Degeneration (AMD). - Anecortave Acetate Risk Reduction Trial (AART)

Phase 1

• Conditions: non-exudative age related macular degeneration (dry AMD)

• Registration Number: EUCTR2005-001598-93-ES
• Lead Sponsor: Alcon Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-22
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

Patients over 50 years of age with a clinical diagnosis of exudative AMD in one eye (non-study eye) and the presence of the following characteristics in the second eye (study eye, eye to be treated):
At least 5 or more intermediate (>63 microns) or larger soft drusen
AND/OR
Confluent drusen within 3000 microns of the foveal center
AND
Hyperpigmentation

Best-corrected ETDRS logMAR visual acuity of 0.30 (equivalent to 20/40 Snellen) or better in the study eye

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Current or history of medical condition that would preclude scheduled study visits or completion of the study.

Current or history of ophthalmic disease in the study eye (other than AMD) that would likely compromise or during follow-up could likely compromise the visual acuity of the study eye.

Clinical signs of myopic retinopathy, or refraction of > –8 diopter power.
Intraocular surgery in study eye (eye to be treated) within 60 days prior to enrolling in the study.

Insertion of a scleral buckle in the study eye (eye to be treated).
Clinical evidence of geographic atrophy (hypopigmentation = 125 microns) in the second eye (eye to be treated).

Evidence of past or present CNV in the study eye. Investigational or approved therapy of any kind for AMD in the study eye.

Intravenous or subcutaneous anticoagulant therapy, or oral anticoagulant therapy (with the exception of aspirin and antiplatelet therapy) and cannot take a 5-day interruption in therapy prior to each depot or sham administration procedure.

Clinical evidence of scleral thinning

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified