A Multi-Dose Study With a Treatment for Open-Angle Glaucoma | NCT00705770

Studies
A Multi-Dose Study With a Treatment for Open-Angle Glaucoma

NCT00705770

Sponsor

Alcon Research

Status

Withdrawn

Last Update Posted

May 30, 2012Estimated

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

Open-Angle Glaucoma

Interventions

Anecortave Acetate
Anecortave Acetate
Anecortave Acetate
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Change in study design

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Jun 24, 2008

First Submission Date that Met QC Criteria

Jun 25, 2008

First Posted Date

Jun 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2012

Last Update Posted Date

May 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Anecortave Acetate	Drug	Low dose Sustained release depot suspension	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Intraocular Pressure		6 months

Secondary Outcomes

Measure	Description	Time Frame
Percent of patients with therapeutic benefit, number and percent of treatment failure and time to treatment failure		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C418047	anecortave acetate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided