Brief Summary

The purpose of this study was to assess the effects of total volume and total dose on the safety and intraocular pressure-lowering efficacy of Anecortave Acetate Suspension (3 mg and 48 mg) in 0.5 mL and 0.8 mL volumes when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

197

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Dec 2008

Shorter than P25 for phase_2

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9 months study duration

First Submitted

Initial submission to the registry

November 7, 2008

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed

20 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed

Last Updated

November 30, 2012

Status Verified

November 1, 2012

Enrollment Period

9 months

First QC Date

November 7, 2008

Last Update Submit

November 28, 2012

Conditions

Open-Angle Glaucoma Ocular Hypertension

Keywords

Open-Angle GlaucomaIntraocular PressureAnecortave Acetate

Outcome Measures

Primary Outcomes (1)

Mean Intraocular Pressure
6 months

Secondary Outcomes (1)

Percent of patients who remain rescue-medication free
6 Months

Study Arms (6)

3 mg Anecortave Acetate, low volume high dose

EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 6 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months.

Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL

3 mg Anecortave Acetate, high volume low dose

EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 3.75 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months.

Drug: Anecortave Acetate Sterile Suspension, 3.75 mg/mL

48 mg Anecortave Acetate, low volume high dose

EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 96 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months.

Drug: Anecortave Acetate Sterile Suspension, 96 mg/mL

48 mg Anecortave Acetate, high volume low dose

EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months.

Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML

Anecortave Acetate Vehicle, low volume

PLACEBO COMPARATOR

Anecortave Acetate Vehicle, one injection of 0.5 mL in the study eye monthly for 6 months.

Other: Anecortave Acetate Vehicle

Anecortave Acetate Vehicle, high volume

PLACEBO COMPARATOR

Anecortave Acetate Vehicle, one injection of 0.8 mL in the study eye monthly for 6 months.

Other: Anecortave Acetate Vehicle