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

This study has been completed.

First Received: July 31, 2003 Last Updated: May 7, 2009 History of Changes

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00065728

Purpose

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

Condition	Intervention	Phase
Macular Degeneration	Drug: Anecortave Acetate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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)

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Anecortave acetate

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

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

Estimated Enrollment:	150
Study Start Date:	May 2003
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065728

Locations

United States, Texas
Belgium,France,Germany,Hungary,Italy,Netherlands,Poland,Spain,Sweden,UK
Central Contact Ft. Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

Investigators

Study Director:

Terry Wiernas, PhD

Alcon Research

More Information

Additional Information:

Click here for more information about this study: A Phase III Clinical Trial for AMD: Information for Potential Participants This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	C-03-15
Study First Received:	July 31, 2003
Last Updated:	May 7, 2009
ClinicalTrials.gov Identifier:	NCT00065728 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

AMD
age-related macular degeneration
Anecortave
Acetate

Wet form of age-related macular degeneration
CNV
Anecortave Acetate

Additional relevant MeSH terms:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on November 09, 2009