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

April 17, 2006
November 27, 2012
December 2005
July 2009   (final data collection date for primary outcome measure)
Mean change in IOP at Week 4 from Baseline [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00315640 on ClinicalTrials.gov Archive Site
Not Provided
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Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Eye Diseases
  • Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL
    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
  • 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
    One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
  • Experimental: Anecortave Acetate 3 mg Depot
    One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
    Intervention: Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL
  • Experimental: Anecortave Acetate 15 mg Depot
    One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
    Intervention: Drug: Anecortave Acetate Suspension Depot, 30 mg/mL
  • Experimental: Anecortave Acetate 30 mg Depot
    One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
    Intervention: Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL
  • Anecortave Acetate Vehicle
    Intervention: Other: Anecortave Acetate Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Hungary,   Italy,   Netherlands,   Puerto Rico,   Spain,   United Kingdom
 
NCT00315640
C-05-03, 2005-001598-93
Not Provided
Alcon Research
Alcon Research
Not Provided
Study Director: Theresa Landry Alcon Research
Alcon Research
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP