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NCT00315640 Clinical Trial

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

Eye Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00315640
Other study ID # C-05-03
Secondary ID 2005-001598-93
Status Completed
Phase Phase 2
First received April 17, 2006
Last updated November 27, 2012
Start date December 2005
Est. completion date July 2009

Study information
Verified date January 2010
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Anecortave Acetate Sterile Suspension, 6 mg/mL
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
• Anecortave Acetate Suspension Depot, 30 mg/mL
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
• 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

Locations
Country Name City State
Brazil San Paulo San Paulo
Hungary Budapest Budapest
Italy Padova Padova
Netherlands Amsterdam Amsterdam
Puerto Rico Bayamon Bayamon
Spain Barcelona Barcelona
United Kingdom Newcastle upon Tyne Newcastle upon Tyne
United States Detroit Detroit Michigan
United States Houston Houston Texas
United States Jacksonville Jacksonville Florida
United States Miami Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Countries where clinical trial is conducted

United States,  Brazil,  Hungary,  Italy,  Netherlands,  Puerto Rico,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change in IOP at Week 4 from Baseline Week 4 No
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