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

NCT ID: NCT00788541

Last Updated: 2012-11-30

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Open-Angle Glaucoma Ocular Hypertension

Keywords

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Open-Angle Glaucoma Intraocular Pressure Anecortave Acetate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 6 mg/mL

Intervention Type DRUG

Administered as an injection into an anterior juxtascleral depot

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.

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 3.75 mg/mL

Intervention Type DRUG

Administered as an injection into an anterior juxtascleral depot

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.

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 96 mg/mL

Intervention Type DRUG

Administered as an injection into an anterior juxtascleral depot

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.

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 60 mg/ML

Intervention Type DRUG

Administered as an injection into an anterior juxtascleral depot

Anecortave Acetate Vehicle, low volume

Anecortave Acetate Vehicle, one injection of 0.5 mL in the study eye monthly for 6 months.

Group Type PLACEBO_COMPARATOR

Anecortave Acetate Vehicle

Intervention Type OTHER

Administered as an injection into an anterior juxtascleral depot

Anecortave Acetate Vehicle, high volume

Anecortave Acetate Vehicle, one injection of 0.8 mL in the study eye monthly for 6 months.

Group Type PLACEBO_COMPARATOR

Anecortave Acetate Vehicle

Intervention Type OTHER

Administered as an injection into an anterior juxtascleral depot

Interventions

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Anecortave Acetate Sterile Suspension, 6 mg/mL

Administered as an injection into an anterior juxtascleral depot

Intervention Type DRUG

Anecortave Acetate Sterile Suspension, 3.75 mg/mL

Administered as an injection into an anterior juxtascleral depot

Intervention Type DRUG

Anecortave Acetate Sterile Suspension, 96 mg/mL

Administered as an injection into an anterior juxtascleral depot

Intervention Type DRUG

Anecortave Acetate Sterile Suspension, 60 mg/ML

Administered as an injection into an anterior juxtascleral depot

Intervention Type DRUG

Anecortave Acetate Vehicle

Administered as an injection into an anterior juxtascleral depot

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Open-Angle Glaucoma or Ocular Hypertension for at least 6 months;

Exclusion Criteria

* Prior angle surgery in the study eye, severe visual field loss in either eye;
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

Locations

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Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-08-049

Identifier Type: -

Identifier Source: org_study_id