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

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