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

This study has been completed.

First Received on July 9, 2002. Last Updated on July 21, 2008 History of Changes

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00041483

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	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind 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:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Verteporfin Anecortave acetate

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Completion Date:

September 2005 (Final data collection date for primary outcome measure)

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
US, Canada, Australia and Europe
Ft. Worth, Texas, United States

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

This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00041483 History of Changes
Other Study ID Numbers:	C-01-99
Study First Received:	July 9, 2002
Last Updated:	July 21, 2008
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 February 12, 2012