Study Stopped
Preliminary data analysis showed insufficient efficacy to justify continuation.
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
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2009
CompletedFirst Posted
Study publicly available on registry
April 20, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
November 17, 2010
CompletedAugust 14, 2018
July 1, 2018
1.3 years
April 17, 2009
September 20, 2010
July 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraocular Pressure Within Normal Limits (<24 mm Hg)
Intraocular pressure was measured by Goldmann applanation tonometry.
1 month
Study Arms (2)
30 mg anecortave acetate
ACTIVE COMPARATOR15 mg anecortave acetate
ACTIVE COMPARATORInterventions
anterior juxtascleral depot of 15 mg anecortave acetate
anterior juxtascleral depot of 30mg anecortave acetate
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Price Vision Group
Indianapolis, Indiana, 46260, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marianne Price, PhD
- Organization
- Cornea Research Foundation of America
Study Officials
- PRINCIPAL INVESTIGATOR
Francis W. Price, Jr., MD
Cornea Research Foundation of America
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2009
First Posted
April 20, 2009
Study Start
May 1, 2009
Primary Completion
August 1, 2010
Study Completion
September 1, 2010
Last Updated
August 14, 2018
Results First Posted
November 17, 2010
Record last verified: 2018-07