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Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00041483
First received: July 9, 2002
Last updated: November 28, 2012
Last verified: July 2008
History of Changes
  Purpose

The purpose of this study is to demonstrate that Anecortave Acetate is as effective after twelve months of treatment as photodynamic therapy (PDT) with Visudyne in patients eligible for initial PDT treatment for wet age-related macular degeneration.


Condition Intervention Phase
Macular Degeneration
 Drug: Anecortave Acetate 15 mg sterile suspension
Other: Photodynamic Therapy (PDT)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD

Resource links provided by NLM:

Drug Information available for: Verteporfin
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Percentage of Patients Maintaining Vision [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Enrollment: 530
Study Start Date: June 2002
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anecortave and Sham PDT Drug: Anecortave Acetate 15 mg sterile suspension Other: Photodynamic Therapy (PDT)
Active Comparator: PDT and Sham Anecortave Acetate Drug: Anecortave Acetate 15 mg sterile suspension Other: Photodynamic Therapy (PDT)

  Eligibility

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

Patients of any race, either gender, aged 50 years and above, diagnosed with subfoveal CNV due to AMD with best corrected logMAR visual acuity of 20/40 (snellen equivalent) to 20/400 (Snellen equivalent) in the study eye. Clinically relevant concomitant diseases will be excluded.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041483

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Ft. Worth, Texas, United States, 76134
Sponsors and Collaborators
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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00041483     History of Changes
Other Study ID Numbers: C-01-99
Study First Received: July 9, 2002
Last Updated: November 28, 2012
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

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Verteporfin
Photosensitizing Agents
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013