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

Intraocular Pressure Clinical Trial

Official title:

Compassionate Use of Anecortave Acetate: Clinical Protocol for the Treatment of Corticosteroid-induced Intraocular Pressure (IOP) Increases After Corneal Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00884039
• Other study ID #: 2007-12
• Status: Terminated
• Phase: N/A
• Start date: May 2009
• Est. completion date: September 2010

Study information

• Verified date: July 2018
• Source: Cornea Research Foundation of America
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intraocular Pressure
• Transplant

Intervention

Drug:
• anecortave acetate
anterior juxtascleral depot of 15 mg anecortave acetate
• 30 mg anecortave acetate
anterior juxtascleral depot of 30mg anecortave acetate

Locations

Country	Name	City	State
United States	Price Vision Group	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Cornea Research Foundation of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure Within Normal Limits (<24 mm Hg)	Intraocular pressure was measured by Goldmann applanation tonometry.	1 month