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Safety and Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma

NCT ID: NCT00451152

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-07-31

Brief Summary

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The purpose of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of anecortave acetate for treatment of elevated IOP in patients with open-angle glaucoma.

Detailed Description

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Conditions

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Open-angle Glaucoma

Keywords

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glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anecortave Acetate Depot

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 30 mg/mL

Intervention Type DRUG

Administered by anterior juxtascleral depot (AJD) in study eye, either 0.25 mL or 0.5 mL. One injection, 24 months.

Anecortave Acetate Vehicle

Group Type PLACEBO_COMPARATOR

Anecortave Acetate Vehicle

Intervention Type OTHER

Administered by anterior juxtascleral depot (AJD) in study eye, 0.5 mL. One injection, 24 months.

Interventions

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Anecortave Acetate Sterile Suspension, 30 mg/mL

Administered by anterior juxtascleral depot (AJD) in study eye, either 0.25 mL or 0.5 mL. One injection, 24 months.

Intervention Type DRUG

Anecortave Acetate Vehicle

Administered by anterior juxtascleral depot (AJD) in study eye, 0.5 mL. One injection, 24 months.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of open-angle glaucoma;

Exclusion Criteria

* Pseudoexfoliation;
* Pigment dispersion component;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Theresa Landry, Ph.D.

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Texas

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-06-19

Identifier Type: -

Identifier Source: org_study_id