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 on July 31, 2003. Last Updated on 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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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: age-related macular degeneration 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

ClinicalTrials.gov Identifier:	NCT00065728 History of Changes
Other Study ID Numbers:	C-03-15
Study First Received:	July 31, 2003
Last Updated:	May 7, 2009
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:

Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012