Anecortave Acetate in Patients With Open-angle Glaucoma

November 27, 2012 updated by: Alcon Research

A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anecortave Acetate 3 mg Depot
Single injection, anterior juxtascleral depot (AJD)
Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL
Single injection, anterior juxtascleral depot (AJD)
Experimental: Anecortave Acetate 15 mg Depot
Single injection, anterior juxtascleral depot (AJD)
Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL
Single injection, anterior juxtascleral depot (AJD)
Experimental: Anecortave Acetate 30 mg Depot
Single injection, anterior juxtascleral depot (AJD)
Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL
Single injection, anterior juxtascleral depot (AJD)
Other: Anecortave Acetate Vehicle
Single injection, anterior juxtascleral depot (AJD)
Other: Anecortave Acetate Vehicle
Single injection, anterior juxtascleral depot (AJD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to treatment failure
Time Frame: At time point
At time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Theresa Landry, Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

May 1, 2006

First Submitted That Met QC Criteria

May 1, 2006

First Posted (Estimate)

May 3, 2006

Study Record Updates

Last Update Posted (Estimate)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-04-62

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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