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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:


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:
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