Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients With AMD

Alcon

Status and phase: Terminated; Phase 3

Conditions: Macular Degeneration

Treatments: Drug: Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00065728

C-03-15

Details and patient eligibility

About

The purpose of this study is to investigate the long-term efficacy and safety of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.

Enrollment: 111 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with subfoveal exudative age-related macular degeneration (AMD) who were previously enrolled in long-term studies with anecortave acetate.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

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 at 6 month intervals for 18 months

Treatment:

Drug: Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL