NCT00705770

Brief Summary

The purpose of this study is to determine whether Anecortave Acetate is effective for lowering intraocular pressure caused by open-angle glaucoma.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2008

Shorter than P25 for phase_2

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2008

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

May 30, 2012

Status Verified

July 1, 2008

Enrollment Period

2 months

First QC Date

June 24, 2008

Last Update Submit

May 29, 2012

Conditions

Open-Angle Glaucoma

Keywords

Open-Angle GlaucomaIntraocular PressureAnecortave Acetate

Outcome Measures

Primary Outcomes (1)

  • Mean Intraocular Pressure

    6 months

Secondary Outcomes (1)

  • Percent of patients with therapeutic benefit, number and percent of treatment failure and time to treatment failure

    6 months

Study Arms (4)

1

PLACEBO COMPARATOR

Placebo treatment with vehicle

Drug: Placebo

2

EXPERIMENTAL

Low dose of study medication

Drug: Anecortave Acetate

3

EXPERIMENTAL

Middle dose of study medication

Drug: Anecortave Acetate

4

EXPERIMENTAL

High dose of study medication

Drug: Anecortave Acetate

Interventions

Anecortave AcetateDRUG

Low dose Sustained release depot suspension

2
PlaceboDRUG

Placebo treatment with vehicle

1

Eligibility Criteria

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

You may qualify if:

  • Patients at least 18 years old with a clinical diagnosis of Open-Angle Glaucoma for at least 6 months and currently treated with a monotherapy hypotensive medication

You may not qualify if:

  • Prior angle surgery in the study eye, severe visual field loss in either eye, and any other form of glaucoma besides open-angle glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

anecortave acetate

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases
0

Study Design

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

Study Record Dates

First Submitted

June 24, 2008

First Posted

June 26, 2008

Study Start

May 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

May 30, 2012

Record last verified: 2008-07