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Anecortave Acetate Safety in Patients With Open-Angle Glaucoma or Ocular Hypertension

NCT ID: NCT00691717

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/PHASE3

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-09-30

Brief Summary

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The purpose of this study was to evaluate the safety and intraocular-lowering efficacy of anecortave acetate depot 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 Oular Hypertension

Keywords

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Anecortave acetate Open-angle glaucoma IOP OHT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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24 mg Anecortave Acetate

Anecortave Acetate Sterile Suspension, 30 mg/mL, single depot administration of 0.8 mL in the study eye

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 30 mg/mL

Intervention Type DRUG

Single administration by anterior juxtascleral depot

48 mg Anecortave Acetate

Anecortave Acetate Sterile Suspension, 60 mg/mL, single depot administration of 0.8 mL in the study eye

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 60 mg/mL

Intervention Type DRUG

Single administration by anterior juxtascleral depot

60 mg Anecortave Acetate

Anecortave Acetate Sterile Suspension, 75 mg/mL, single depot administration of 0.8 mL in the study eye

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 75 mg/mL

Intervention Type DRUG

Single administration by anterior juxtascleral depot

Anecortave Acetate Vehicle

Single depot administration of 0.8 mL in the study eye

Group Type PLACEBO_COMPARATOR

Anecortave Acetate Vehicle

Intervention Type OTHER

Single administration by anterior juxtascleral depot

Interventions

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Anecortave Acetate Sterile Suspension, 30 mg/mL

Single administration by anterior juxtascleral depot

Intervention Type DRUG

Anecortave Acetate Sterile Suspension, 60 mg/mL

Single administration by anterior juxtascleral depot

Intervention Type DRUG

Anecortave Acetate Sterile Suspension, 75 mg/mL

Single administration by anterior juxtascleral depot

Intervention Type DRUG

Anecortave Acetate Vehicle

Single administration by anterior juxtascleral depot

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years of age or older with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation) or ocular hypertension.

Exclusion Criteria

* Patients with any form of glaucoma other than open-angle.
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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Charleston

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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C-07-36

Identifier Type: -

Identifier Source: org_study_id