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

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT00691717

Collaborator

(none)

201

Enrollment

Location

Arms

Duration (Months)

13.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma Oular Hypertension	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	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

201 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 24 mg Anecortave Acetate Anecortave Acetate Sterile Suspension, 30 mg/mL, single depot administration of 0.8 mL in the study eye	Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL Single administration by anterior juxtascleral depot
Experimental: 48 mg Anecortave Acetate Anecortave Acetate Sterile Suspension, 60 mg/mL, single depot administration of 0.8 mL in the study eye	Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL Single administration by anterior juxtascleral depot
Experimental: 60 mg Anecortave Acetate Anecortave Acetate Sterile Suspension, 75 mg/mL, single depot administration of 0.8 mL in the study eye	Drug: Anecortave Acetate Sterile Suspension, 75 mg/mL Single administration by anterior juxtascleral depot
Placebo Comparator: Anecortave Acetate Vehicle Single depot administration of 0.8 mL in the study eye	Other: Anecortave Acetate Vehicle Single administration by anterior juxtascleral depot

Outcome Measures

Primary Outcome Measures

Mean Intraocular Pressure at 8 am [Up to 6 months]

Secondary Outcome Measures

Percent of Patients Who Remained Rescue Medication-Free at Month 3 (8 am) [Month 3, 8 am]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.