Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients With AMD - Tabular View

Tracking Information

First Received Date ^ICMJE

July 31, 2003

Last Updated Date

May 7, 2009

Start Date ^ICMJE

May 2003

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent of patients who maintain a positive visual acuity outcome and mean change from baseline in logMAR visual acuity score

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00065728 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Not applicable

Descriptive Information

Brief Title ^ICMJE

Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients With AMD

Official Title ^ICMJE

An Open Label Evaluation of Long Term Efficacy and Safety of Posterior Juxtascleral Injections of Anecortave Acetate 15 mg in Patients With Subfoveal Exudative Age-Related Macular Degeneration (AMD)

Brief Summary

This is a 24 month study of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.

Detailed Description

Patients will receive posterior juxtascleral injections of 15 mg Anecortave Acetate Sterile Suspension at 6-month intervals during the 24-month study. The patients will receive periodic visual acuity evaluations during the study.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Macular Degeneration

Intervention ^ICMJE

Drug: Anecortave Acetate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

150

Completion Date

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Patients with subfoveal exudative age-related macular degeneration (AMD) who were previously enrolled in long-term studies with anecortave acetate.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00065728

Responsible Party

Study ID Numbers ^ICMJE

C-03-15

Study Sponsor ^ICMJE

Alcon Research

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Terry Wiernas, PhD

Alcon Research

Information Provided By

Alcon Research

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP