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

Cornea Research Foundation of America

Status: Terminated

Conditions: Intraocular Pressure; Transplant

Treatments: Drug: 30 mg anecortave acetate; Drug: anecortave acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT00884039

2007-12

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7 participants in 2 patient groups

30 mg anecortave acetate

Active Comparator group

Treatment:

Drug: 30 mg anecortave acetate

15 mg anecortave acetate

Active Comparator group

Treatment:

Drug: anecortave acetate