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

Phase 3TerminatedNCT00065728

Alcon Research111 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

111

Conditions

Macular Degeneration

Interventions

Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mLDRUG

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Belgium,France,Germany,Hungary,Italy,Netherlands,Poland,Spain,Sweden,UK

Central Contact Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Percent of patients who maintained stable vision

Stable vision is defined as \< 15-letter loss of best-corrected visual acuity scores)

Time frame: Month 24

Mean change in best-corrected visual acuity at Month 24 from baseline

Time frame: Baseline, Month 24

Data from ClinicalTrials.gov

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