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

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ClinicalTrials.gov Identifier: NCT00884039
Recruitment Status : Terminated (Preliminary data analysis showed insufficient efficacy to justify continuation.)
First Posted : April 20, 2009
Results First Posted : November 17, 2010
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):
Cornea Research Foundation of America

Brief Summary:
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 or disease Intervention/treatment Phase
Transplant Intraocular Pressure Drug: anecortave acetate Drug: 30 mg anecortave acetate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Intraocular Pressure Within Normal Limits (<24 mm Hg) [ Time Frame: 1 month ]
    Intraocular pressure was measured by Goldmann applanation tonometry.

  2. Change in Intraocular Pressure [ Time Frame: 1 week, 2 weeks, and monthly through 6 months after treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Cornea Research Foundation of America
ClinicalTrials.gov Identifier: NCT00884039     History of Changes
Other Study ID Numbers: 2007-12
First Posted: April 20, 2009    Key Record Dates
Results First Posted: November 17, 2010
Last Update Posted: August 6, 2014
Last Verified: August 2014

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

Additional relevant MeSH terms:
Anecortave
Hydrocortisone
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents