Title

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
  • Phase

    N/A
  • Study Type

    Interventional
  • Intervention/Treatment

    retaane ...
  • Study Participants

    7
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.
Study Started
May 31
2009
Primary Completion
Aug 31
2010
Study Completion
Sep 30
2010
Results Posted
Nov 17
2010
Estimate
Last Update
Aug 14
2018

Drug 30 mg anecortave acetate

anterior juxtascleral depot of 30mg anecortave acetate

Drug anecortave acetate

anterior juxtascleral depot of 15 mg anecortave acetate

30 mg anecortave acetate Active Comparator

15 mg anecortave acetate Active Comparator

Criteria

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

Summary

30 mg Anecortave Acetate

15 mg Anecortave Acetate

All Events

Event Type Organ System Event Term 30 mg Anecortave Acetate 15 mg Anecortave Acetate

Intraocular Pressure Within Normal Limits (<24 mm Hg)

Intraocular pressure was measured by Goldmann applanation tonometry.

30 mg Anecortave Acetate

2.0
Participants

15 mg Anecortave Acetate

1.0
Participants

Total

7
Participants

Age, Continuous

65
years (Mean)
Standard Deviation: 16

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

30 mg Anecortave Acetate

15 mg Anecortave Acetate

Drop/Withdrawal Reasons

30 mg Anecortave Acetate

15 mg Anecortave Acetate