NCT00315640

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of anecortave acetate depot when administered for the treatment of elevated IOP following treatment with steroids.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2005

Typical duration for phase_2

Geographic Reach
8 countries

12 active sites

Status
completed

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

December 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2006

Completed
3.2 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

January 1, 2010

Enrollment Period

3.6 years

First QC Date

April 17, 2006

Last Update Submit

November 27, 2012

Conditions

Eye Diseases

Keywords

Elevated IOP due to intravitreal triamcinolone therapy

Outcome Measures

Primary Outcomes (1)

  • Mean change in IOP at Week 4 from Baseline

    Week 4

Study Arms (4)

Anecortave Acetate 3 mg Depot

EXPERIMENTAL

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL

Anecortave Acetate 15 mg Depot

EXPERIMENTAL

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Drug: Anecortave Acetate Suspension Depot, 30 mg/mL

Anecortave Acetate 30 mg Depot

EXPERIMENTAL

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL

Anecortave Acetate Vehicle

OTHER
Other: Anecortave Acetate Vehicle

Interventions

Anecortave Acetate Sterile Suspension, 6 mg/mLDRUG

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

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

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

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

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Anecortave Acetate 30 mg Depot
Anecortave Acetate VehicleOTHER

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Anecortave Acetate Vehicle

Eligibility Criteria

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

You may qualify if:

  • Either gender
  • years of age or older
  • IOP elevation caused by steroid usage

You may not qualify if:

  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Jacksonville

Jacksonville, Florida, 32204, United States

Location

Miami

Miami, Florida, 33136, United States

Location

Detroit

Detroit, Michigan, 48202, United States

Location

Unknown Facility

Fort Worth, Texas, 76134, United States

Location

Houston

Houston, Texas, 77030, United States

Location

San Paulo

São Paulo, Brazil

Location

Budapest

Budapest, Hungary

Location

Padova

Padua, Italy

Location

Amsterdam

Amsterdam, Netherlands

Location

Bayamon

Bayamón, 00961, Puerto Rico

Location

Barcelona

Barcelona, Spain

Location

Newcastle upon Tyne

Newcastle upon Tyne, United Kingdom

Location

MeSH Terms

Conditions

Eye Diseases

Interventions

anecortave acetate

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

April 17, 2006

First Posted

April 19, 2006

Study Start

December 1, 2005

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 28, 2012

Record last verified: 2010-01

Locations

GB(1)HU(1)US(5)NL(1)IT(1)PR(1)ES(1)BR(1)