Anecortave Acetate Safety in Patients With Open-Angle Glaucoma or Ocular Hypertension

Phase 2

Completed

• Conditions: Open-angle Glaucoma; Oular Hypertension
• Interventions: Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL; Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL; Drug: Anecortave Acetate Sterile Suspension, 75 mg/mL; Other: Anecortave Acetate Vehicle

• Registration Number: NCT00691717
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to evaluate the safety and intraocular-lowering efficacy of anecortave acetate depot when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-05
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2012-11
• Disposition First Submitted: 2012-11-27
• Disposition First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Disposition First Posted: 2012-11-28
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• Patients 18 years of age or older with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation) or ocular hypertension.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Patients with any form of glaucoma other than open-angle.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24 mg Anecortave Acetate	Anecortave Acetate Sterile Suspension, 30 mg/mL	Anecortave Acetate Sterile Suspension, 30 mg/mL, single depot administration of 0.8 mL in the study eye
48 mg Anecortave Acetate	Anecortave Acetate Sterile Suspension, 60 mg/mL	Anecortave Acetate Sterile Suspension, 60 mg/mL, single depot administration of 0.8 mL in the study eye
60 mg Anecortave Acetate	Anecortave Acetate Sterile Suspension, 75 mg/mL	Anecortave Acetate Sterile Suspension, 75 mg/mL, single depot administration of 0.8 mL in the study eye
Anecortave Acetate Vehicle	Anecortave Acetate Vehicle	Single depot administration of 0.8 mL in the study eye

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure at 8 am	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
Percent of Patients Who Remained Rescue Medication-Free at Month 3 (8 am)	Month 3, 8 am

Trial Locations

Locations (1)

Charleston; 🇺🇸 Charleston, South Carolina, United States