NCT00320203

Brief Summary

The purpose of this study is to evaluate the safety, efficacy, and duration of effect of a single administration of Anecortave Acetate Depot for treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2006

Status
completed

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

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

November 28, 2012

Status Verified

February 1, 2008

Enrollment Period

1.8 years

First QC Date

May 1, 2006

Last Update Submit

November 27, 2012

Conditions

Open-angle Glaucoma

Keywords

open-angleglaucoma

Outcome Measures

Primary Outcomes (1)

  • Mean change in intraocular pressure at 9 am from baseline

    Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12

Secondary Outcomes (1)

  • Time to treatment failure

    At time point

Study Arms (4)

Anecortave Acetate 3 mg Depot

EXPERIMENTAL

Single injection, anterior juxtascleral depot (AJD)

Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL

Anecortave Acetate 15 mg Depot

EXPERIMENTAL

Single injection, anterior juxtascleral depot (AJD)

Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL

Anecortave Acetate 30 mg Depot

EXPERIMENTAL

Single injection, anterior juxtascleral depot (AJD)

Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL

Anecortave Acetate Vehicle

OTHER

Single injection, anterior juxtascleral depot (AJD)

Other: Anecortave Acetate Vehicle

Interventions

Anecortave Acetate Sterile Suspension, 6 mg/mLDRUG

Single injection, anterior juxtascleral depot (AJD)

Anecortave Acetate 3 mg Depot
Anecortave Acetate Sterile Suspension, 30 mg/mLDRUG

Single injection, anterior juxtascleral depot (AJD)

Anecortave Acetate 15 mg Depot
Anecortave Acetate Sterile Suspension, 60 mg/mLDRUG

Single injection, anterior juxtascleral depot (AJD)

Anecortave Acetate 30 mg Depot
Anecortave Acetate VehicleOTHER

Single injection, anterior juxtascleral depot (AJD)

Anecortave Acetate Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years of age or older with open-angle glaucoma.

You may not qualify if:

  • Patients with open-angle glaucoma with a pseudoexfoliation or pigment dispersion component.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Interventions

anecortave acetate

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Theresa Landry

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2006

First Posted

May 3, 2006

Study Start

March 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

November 28, 2012

Record last verified: 2008-02