Anecortave Acetate in Patients With Exudative Age-Related Macular Degeneration (AMD)

This study is ongoing, but not recruiting participants.

First Received: March 3, 2006 Last Updated: April 21, 2008 History of Changes

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00299507

Purpose

In this study patients will receive a posterior juxtascleral administration of anecortave acetate for depot suspension 15 mg every three months versus 15 mg every six months versus 30 mg every six months during the 24-month study. The patient will receive periodic ocular evaluations during the study.

Condition	Intervention	Phase
Macular Degeneration	Drug: anecortave acetate	Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Anecortave acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Anecortave Acetate 15 mg Administered Every 3 Months Versus Anecortave Acetate 15 mg Administered Every 6 Months Versus Anecortave Acetate 30 mg Administered Every 6 Months in Patients With Exudative Age-Related Macular Degeneration (AMD)

Further study details as provided by Alcon Research:

Primary Outcome Measures:

mean change from baseline in logMAR visual acuity score

Secondary Outcome Measures:

mean change from baseline in lesion size

Estimated Enrollment:	288
Study Start Date:	March 2005

Eligibility

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

Criteria

Inclusion Criteria:

Clinical diagnosis of exudative AMD and a primary or recurrent (after laser photocoagulation) subfoveal choroidal neovascularization (CNV) lesion

Exclusion Criteria:

Less than 50 years of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299507

Locations

United States, Texas
Alcon Study Sites
Fort Worth, Texas, United States

Sponsors and Collaborators

Alcon Research

Investigators

Principal Investigator:	Alcon Investigators	Alcon Research
Study Director:	Patricia Zilliox, Ph.D.	Alcon Research

More Information

No publications provided

Study ID Numbers:	C-04-59
Study First Received:	March 3, 2006
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00299507 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

exudative AMD
age-related macular degeneration (AMD)

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

Additional relevant MeSH terms:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on May 06, 2009