Anecortave Acetate Risk Reduction Trial (AART)

Alcon

Status and phase: Terminated; Phase 3

Conditions: AMD

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00332657

C-05-34

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Dry AMD in study eye, Wet AMD 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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36 participants in 3 patient groups

Anecortave Acetate, 15 mg

Experimental group

Description:

One 0.5 mL injection of 30 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months.

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL

Anecortave Acetate, 30 mg

Experimental group

Description:

One 0.5 mL injection of 60 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months.

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL

Anecortave Acetate Vehicle

Sham Comparator group

Description:

One sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.

Treatment:

Other: Anecortave Acetate Vehicle