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

November 27, 2012 updated by: Alcon Research

A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

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

  • Brazil
      • San Paulo, Brazil
        • San Paulo
  • Hungary
      • Budapest, Hungary
        • Budapest
  • Italy
      • Padova, Italy
        • Padova
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam
  • Puerto Rico
      • Bayamon, Puerto Rico, 00961
        • Bayamon
  • Spain
      • Barcelona, Spain
        • Barcelona
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom
        • Newcastle upon Tyne
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Jacksonville
      • Miami, Florida, United States, 33136
        • Miami
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Detroit
    • Texas
      • Fort Worth, Texas, United States, 76134
      • Houston, Texas, United States, 77030
        • Houston

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:

  • Either gender
  • 18 years of age or older
  • IOP elevation caused by steroid usage
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Under 18 years of age
  • 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
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Experimental: Anecortave Acetate 15 mg Depot
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Drug: Anecortave Acetate Suspension Depot, 30 mg/mL
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Experimental: Anecortave Acetate 30 mg Depot
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Other: Anecortave Acetate Vehicle
Other: Anecortave Acetate Vehicle
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in IOP at Week 4 from Baseline
Time Frame: Week 4
Week 4

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

December 1, 2005

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

April 17, 2006

First Submitted That Met QC Criteria

April 17, 2006

First Posted (Estimate)

April 19, 2006

Study Record Updates

Last Update Posted (Estimate)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-05-03
  • 2005-001598-93

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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