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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00315640
First received: April 17, 2006
Last updated: November 27, 2012
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Eye Diseases
Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL
Drug: Anecortave Acetate Suspension Depot, 30 mg/mL
Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL
Other: Anecortave Acetate Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean change in IOP at Week 4 from Baseline [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: December 2005
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Anecortave Acetate Vehicle Other: Anecortave Acetate Vehicle
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315640

Locations
United States, Florida
Jacksonville
Jacksonville, Florida, United States, 32204
Miami
Miami, Florida, United States, 33136
United States, Michigan
Detroit
Detroit, Michigan, United States, 48202
United States, Texas
Fort Worth, Texas, United States, 76134
Houston
Houston, Texas, United States, 77030
Brazil
San Paulo
San Paulo, Brazil
Hungary
Budapest
Budapest, Hungary
Italy
Padova
Padova, Italy
Netherlands
Amsterdam
Amsterdam, Netherlands
Puerto Rico
Bayamon
Bayamon, Puerto Rico, 00961
Spain
Barcelona
Barcelona, Spain
United Kingdom
Newcastle upon Tyne
Newcastle upon Tyne, United Kingdom
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Theresa Landry Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00315640     History of Changes
Other Study ID Numbers: C-05-03, 2005-001598-93
Study First Received: April 17, 2006
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Elevated IOP due to intravitreal triamcinolone therapy

Additional relevant MeSH terms:
Eye Diseases

ClinicalTrials.gov processed this record on July 24, 2014