A Dose-Volume Study of a Treatment for Elevated IOP Due to Open-Angle Glaucoma or Ocular Hypertension

November 28, 2012 updated by: Alcon Research

A Dose-Volume Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study was to assess the effects of total volume and total dose on the safety and intraocular pressure-lowering efficacy of Anecortave Acetate Suspension (3 mg and 48 mg) in 0.5 mL and 0.8 mL volumes when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center for Trial Locations

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:

  • Clinical diagnosis of Open-Angle Glaucoma or Ocular Hypertension for at least 6 months;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Prior angle surgery in the study eye, severe visual field loss in either eye;
  • 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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 3 mg Anecortave Acetate, low volume high dose
Anecortave Acetate Sterile Suspension, 6 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months.
Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL
Administered as an injection into an anterior juxtascleral depot
EXPERIMENTAL: 3 mg Anecortave Acetate, high volume low dose
Anecortave Acetate Sterile Suspension, 3.75 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months.
Drug: Anecortave Acetate Sterile Suspension, 3.75 mg/mL
Administered as an injection into an anterior juxtascleral depot
EXPERIMENTAL: 48 mg Anecortave Acetate, low volume high dose
Anecortave Acetate Sterile Suspension, 96 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months.
Drug: Anecortave Acetate Sterile Suspension, 96 mg/mL
Administered as an injection into an anterior juxtascleral depot
EXPERIMENTAL: 48 mg Anecortave Acetate, high volume low dose
Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months.
Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML
Administered as an injection into an anterior juxtascleral depot
PLACEBO_COMPARATOR: Anecortave Acetate Vehicle, low volume
Anecortave Acetate Vehicle, one injection of 0.5 mL in the study eye monthly for 6 months.
Other: Anecortave Acetate Vehicle
Administered as an injection into an anterior juxtascleral depot
PLACEBO_COMPARATOR: Anecortave Acetate Vehicle, high volume
Anecortave Acetate Vehicle, one injection of 0.8 mL in the study eye monthly for 6 months.
Other: Anecortave Acetate Vehicle
Administered as an injection into an anterior juxtascleral depot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Intraocular Pressure
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent of patients who remain rescue-medication free
Time Frame: 6 Months
6 Months

Collaborators and Investigators

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

Sponsor

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

December 1, 2008

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (ESTIMATE)

November 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 28, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-08-049

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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