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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
  Purpose

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.


Condition Intervention
Transplant
Intraocular Pressure
 Drug: anecortave acetate
Drug: 30 mg anecortave acetate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compassionate Use of Anecortave Acetate: Clinical Protocol for the Treatment of Corticosteroid-induced Intraocular Pressure (IOP) Increases After Corneal Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cornea Research Foundation of America:

Primary Outcome Measures:
  • 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 ]

Enrollment: 7
Study Start Date: May 2009
Study Completion Date: September 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 30 mg anecortave acetate Drug: 30 mg anecortave acetate
anterior juxtascleral depot of 30mg anecortave acetate
Active Comparator: 15 mg anecortave acetate Drug: anecortave acetate
anterior juxtascleral depot of 15 mg anecortave acetate

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884039

Locations
United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
Sponsors and Collaborators
Cornea Research Foundation of America
Investigators
Principal Investigator: Francis W. Price, Jr., MD Cornea Research Foundation of America
  More Information

No publications provided

Responsible Party: Dr. Francis W. Price, Jr. MD, Cornea Research Foundation of America
ClinicalTrials.gov Identifier: NCT00884039     History of Changes
Other Study ID Numbers: 2007-12
Study First Received: April 17, 2009
Results First Received: September 20, 2010
Last Updated: October 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Cornea Research Foundation of America:
cornea
transplant
intraocular pressure
steroid response

ClinicalTrials.gov processed this record on May 21, 2013