IOP Reduction After Anecortave Acetate Injection in Glauc... | NCT00533962

Studies
IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients

NCT00533962

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

Sep 24, 2007Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Glaucoma
Intraocular Pressure

Interventions

Anterior Juxtascleral Depot of Anecortave Acetate

Countries

Brazil

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

Sep 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 20, 2007

First Submission Date that Met QC Criteria

Sep 21, 2007

First Posted Date

Sep 24, 2007Estimated

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

Sep 21, 2007

Last Update Posted Date

Sep 24, 2007Estimated

Name	Class
Alcon Research	INDUSTRY

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

Introduction: Ocular administration of glucocorticoids is a common and effective treatment for several ocular diseases. However it is often complicated with the elevation of intraocular pressure (IOP). Anecortave acetate (AA) is an analog of cortisol acetate and lacks the typical anti-inflammatory and immunosuppressive properties of glucocorticoids. The effect of its anterior juxtascleral depot (AJD) injection has been evaluated in cases of glaucoma caused by intravitreal triamcinolone acetonide, presenting impressive results. The purpose of this study is to evaluate the efficacy and safety of the AA injection as a possible antiglaucoma treatment alternative. Methods: A prospective clinical study will be carried out including 30 glaucoma patients (30 eyes). After inclusion each patient will receive a single AJD injection of 30 mg of AA in the selected eye. Main outcome measure include: intraocular pressure at 1st day, 7th day, 1st, 2nd and 3rd months.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Name	Type	Description	Arm Group Labels	Other Names
Anterior Juxtascleral Depot of Anecortave Acetate	Drug

Measure	Description	Time Frame
Intraocular pressure		Procedure

Measure	Description	Time Frame
Visual Acuity; side effects (biomicroscopy exam)		Post treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced glaucoma cases with surgery or cyclophotocoagulation indication (IOP over 25 mmHg)
Patients should be under maximum tolerated medication
Low best corrected visual acuity (worse than 20/100)

Exclusion Criteria:

Under 18 or over 80

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tiago Prata	Federal University of São Paulo	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
São Paulo		São Paulo	São Paulo	01404-001	Brazil

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases