Anecortave Acetate Risk-Reduction Trial (AART)

Phase 3TerminatedNCT00307398

Alcon Research2,596 enrolled

Overview

A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg or sham administration every 6 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,596

Conditions

Dry AMD

Interventions

Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mgDRUG

One 0.5 mL injection of 30 mg/mL (AA 15 mg) or one 0.5 mL injection of 60 mg/mL (AA 30 mg) into a posterior juxtascleral depot (PJD) at 6-month intervals.

Anecortave Acetate VehicleOTHER

One 0.5 mL sham injection at 6-month intervals. Syringe containing AA vehicle was not inserted into the eye.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Study Centers in the United States and Globally

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48

ST-CNV is defined as CNV or a portion of CNV within 2500 microns of the foveal center, as evidenced by digital angiography at the clinical site.

Time frame: Month 48

Data from ClinicalTrials.gov

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