Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation

NCT ID: NCT00315640

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-07-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of anecortave acetate depot when administered for the treatment of elevated IOP following treatment with steroids.

Detailed Description

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Conditions

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Eye Diseases

Keywords

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Elevated IOP due to intravitreal triamcinolone therapy

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 3 mg Depot

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 6 mg/mL

Intervention Type DRUG

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Anecortave Acetate 15 mg Depot

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Group Type EXPERIMENTAL

Anecortave Acetate Suspension Depot, 30 mg/mL

Intervention Type DRUG

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Anecortave Acetate 30 mg Depot

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 60 mg/mL

Intervention Type DRUG

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Anecortave Acetate Vehicle

Group Type OTHER

Anecortave Acetate Vehicle

Intervention Type OTHER

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Interventions

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Anecortave Acetate Sterile Suspension, 6 mg/mL

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Intervention Type DRUG

Anecortave Acetate Suspension Depot, 30 mg/mL

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Intervention Type DRUG

Anecortave Acetate Sterile Suspension, 60 mg/mL

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Intervention Type DRUG

Anecortave Acetate Vehicle

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Either gender
* 18 years of age or older
* IOP elevation caused by steroid usage

Exclusion Criteria

* Under 18 years of age
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

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Jacksonville

Jacksonville, Florida, United States

Site Status

Miami

Miami, Florida, United States

Site Status

Detroit

Detroit, Michigan, United States

Site Status

Fort Worth, Texas, United States

Site Status

Houston

Houston, Texas, United States

Site Status

San Paulo

São Paulo, , Brazil

Site Status

Budapest

Budapest, , Hungary

Site Status

Padova

Padua, , Italy

Site Status

Amsterdam

Amsterdam, , Netherlands

Site Status

Bayamon

Bayamón, , Puerto Rico

Site Status

Barcelona

Barcelona, , Spain

Site Status

Newcastle upon Tyne

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States Brazil Hungary Italy Netherlands Puerto Rico Spain United Kingdom

Other Identifiers

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2005-001598-93

Identifier Type: -

Identifier Source: secondary_id

C-05-03

Identifier Type: -

Identifier Source: org_study_id