Anecortave Acetate Risk-Reduction Trial (AART)

Alcon

Status and phase: Terminated; Phase 3

Conditions: Dry AMD

Treatments: Drug: Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg; Other: Anecortave Acetate Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00307398

C-02-60

Details and patient eligibility

About

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

Enrollment: 2,596 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,596 participants in 2 patient groups

AL-3789

Experimental group

Description:

One injection to the study eye by the posterior juxtascleral depot procedure at 6-month intervals for 42 months.

Treatment:

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

Anecortave Acetate Vehicle

Sham Comparator group

Description:

One sham injection to the study eye at 6-month intervals for 42 months. Syringe containing AA vehicle was not inserted into the eye.

Treatment:

Other: Anecortave Acetate Vehicle