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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:
ClinicalTrials.gov Identifier:
NCT00884039
First Posted: April 20, 2009
Last Update Posted: August 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cornea Research Foundation of America
  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
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

Resource links provided by NLM:


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 ]
    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 ]

Enrollment: 7
Study Start Date: May 2009
Study Completion Date: September 2010
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

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Cornea Research Foundation of America
ClinicalTrials.gov Identifier: NCT00884039     History of Changes
Other Study ID Numbers: 2007-12
First Submitted: April 17, 2009
First Posted: April 20, 2009
Results First Submitted: September 20, 2010
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