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

Not Applicable

Terminated

• Conditions: Transplant; Intraocular Pressure
• Interventions: Drug: 30 mg anecortave acetate; Drug: anecortave acetate

• Registration Number: NCT00884039
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Study Start: 2009-05
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Results First Submitted: 2010-09-20
• Results First Submitted QC: 2010-10-21
• Results First Posted: 2010-11-17
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30 mg anecortave acetate	30 mg anecortave acetate	-
15 mg anecortave acetate	anecortave acetate	-

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure Within Normal Limits (<24 mm Hg)	1 month	Intraocular pressure was measured by Goldmann applanation tonometry.

Trial Locations

Locations (1)

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States