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



Status:Terminated
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:8/16/2018
Start Date:May 2009
End Date:September 2010

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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.


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
We found this trial at
1
site
Indianapolis, Indiana 46260
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Indianapolis, IN
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