NCT00451152

Brief Summary

The purpose of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of anecortave acetate for treatment of elevated IOP in patients with open-angle glaucoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

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, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 28, 2012

Status Verified

May 1, 2012

Enrollment Period

2.3 years

First QC Date

March 21, 2007

Last Update Submit

November 27, 2012

Conditions

Open-angle Glaucoma

Keywords

glaucoma

Outcome Measures

Primary Outcomes (1)

  • Mean Intraocular Pressure (IOP)

    3 months

Secondary Outcomes (1)

  • Percent Treatment Failures

    3 months

Study Arms (2)

Anecortave Acetate Depot

EXPERIMENTAL
Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL

Anecortave Acetate Vehicle

PLACEBO COMPARATOR
Other: Anecortave Acetate Vehicle

Interventions

Anecortave Acetate Sterile Suspension, 30 mg/mLDRUG

Administered by anterior juxtascleral depot (AJD) in study eye, either 0.25 mL or 0.5 mL. One injection, 24 months.

Anecortave Acetate Depot
Anecortave Acetate VehicleOTHER

Administered by anterior juxtascleral depot (AJD) in study eye, 0.5 mL. One injection, 24 months.

Anecortave Acetate Vehicle

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of open-angle glaucoma;

You may not qualify if:

  • Pseudoexfoliation;
  • Pigment dispersion component;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas

San Antonio, Texas, 78257, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Interventions

anecortave acetate

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Theresa Landry, Ph.D.

    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

March 21, 2007

First Posted

March 23, 2007

Study Start

March 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 28, 2012

Record last verified: 2012-05

Locations

US(1)