Anecortave Acetate in Patients With Open-angle Glaucoma

Phase 2CompletedNCT00320203

Alcon Research86 enrolled

Overview

The purpose of this study is to evaluate the safety, efficacy, and duration of effect of a single administration of Anecortave Acetate Depot for treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Open-angle Glaucoma

Interventions

Anecortave Acetate Sterile Suspension, 6 mg/mLDRUG

Single injection, anterior juxtascleral depot (AJD)

Anecortave Acetate Sterile Suspension, 30 mg/mLDRUG

Single injection, anterior juxtascleral depot (AJD)

Anecortave Acetate Sterile Suspension, 60 mg/mLDRUG

Single injection, anterior juxtascleral depot (AJD)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients 18 years of age or older with open-angle glaucoma. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Patients with open-angle glaucoma with a pseudoexfoliation or pigment dispersion component. * Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Mean change in intraocular pressure at 9 am from baseline

Time frame: Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12

Secondary Outcomes

Time to treatment failure

Time frame: At time point

Data from ClinicalTrials.gov

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