Anecortave Acetate Risk-Reduction Trial (AART)

Alcon

Status and phase: Terminated; Phase 3

Conditions: AMD

Treatments: Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML; Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL; Other: Anecortave Acetate Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00333216

C-04-30

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups

15 mg Anecortave Acetate

Experimental group

Description:

Anecortave Acetate Sterile Suspension, 30 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL

30 mg Anecortave Acetate

Experimental group

Description:

Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML

Anecortave Acetate Vehicle

Sham Comparator group

Description:

Anecortave Acetate Vehicle, one sham injection in the study eye every 6 months for 48 months

Treatment:

Other: Anecortave Acetate Vehicle