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Anecortave Acetate Injection to Treat Steroid-responsive Intraocular Pressure Increase in Cornea Transplant Patients

This study has been terminated.
(Preliminary data analysis showed insufficient efficacy to justify continuation.)
Sponsor:
Information provided by:
Cornea Research Foundation of America
ClinicalTrials.gov Identifier:
NCT00884039
First received: April 17, 2009
Last updated: October 21, 2010
Last verified: October 2010
History of Changes

April 17, 2009
October 21, 2010
May 2009
August 2010   (final data collection date for primary outcome measure)
  • Intraocular Pressure Within Normal Limits (<24 mm Hg) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Intraocular pressure was measured by Goldmann applanation tonometry.
  • Change in Intraocular Pressure [ Time Frame: 1 week, 2 weeks, and monthly through 6 months after treatment ] [ Designated as safety issue: No ]
Change in Intraocular Pressure [ Time Frame: 1 week, 2 weeks, and monthly through 6 months after treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00884039 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Anecortave Acetate Injection to Treat Steroid-responsive Intraocular Pressure Increase in Cornea Transplant Patients
Compassionate Use of Anecortave Acetate: Clinical Protocol for the Treatment of Corticosteroid-induced Intraocular Pressure (IOP) Increases After Corneal Transplantation

This study will investigate the use of anecortave acetate injection to reduce intraocular pressure (IOP) in corneal transplant recipients who are experiencing steroid-associated pressure control problems. Alternative methods of IOP control have been shown to entail serious risks. For example, reduction of topical steroids increases the risk of graft rejection, and use of glaucoma medications or glaucoma surgery increases the risk of graft failure. This study is designed to have sufficient power to detect whether a single injection can induce a clinically significant IOP reduction.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Transplant
  • Intraocular Pressure
  • Drug: anecortave acetate
    anterior juxtascleral depot of 15 mg anecortave acetate
  • Drug: 30 mg anecortave acetate
    anterior juxtascleral depot of 30mg anecortave acetate
  • Active Comparator: 30 mg anecortave acetate
    Intervention: Drug: 30 mg anecortave acetate
  • Active Comparator: 15 mg anecortave acetate
    Intervention: Drug: anecortave acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
September 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • at least 18 years of age
  • corneal transplant recipient with intraocular pressure (IOP) greater than 24 mmHg and with relative increase in IOP of at least 10 mmHg over the pre-graft baseline

Exclusion Criteria:

  • not pregnant or lactating
  • intraocular surgery in the study eye within 30 days before enrolling in the study
  • use of any investigational drug or treatment within 30 days before receipt of study medication
  • clinical evidence of scleral thinning
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00884039
2007-12
Yes
Dr. Francis W. Price, Jr. MD, Cornea Research Foundation of America
Cornea Research Foundation of America
Not Provided
Principal Investigator: Francis W. Price, Jr., MD Cornea Research Foundation of America
Cornea Research Foundation of America
October 2010

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