Anecortave Acetate Risk-Reduction Trial (AART)

Phase 3TerminatedNCT00333216

Alcon Research24 enrolled

Overview

The purpose of this study was to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry) age-related macular degeneration in patients who are at risk for progressing to exudative (wet) age-related macular degeneration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

AMD

Interventions

Anecortave Acetate Sterile Suspension, 30 mg/mLDRUG

Posterior juxtascleral administration of suspension

Anecortave Acetate Sterile Suspension, 60 mg/MLDRUG

Posterior juxtascleral administration of suspension

Anecortave Acetate VehicleOTHER

Sham posterior juxtascleral administration of suspension

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Dry AMD in study eye, Wet AMD in non-study eye; * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Under 50; * Other protocol-defined exclusion criteria may apply.

Locations (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Proportion of patients with sight-threatening CNV in study eye

Time frame: Month 48

Secondary Outcomes

Time to development of sight-threatening CNV

Time frame: Up to 48 months

Proportion of patients with stable vision

Time frame: Up to 48 months

Data from ClinicalTrials.gov

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