A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD

This study is currently recruiting participants.

Verified by Eyetech Pharmaceuticals, January 2007

Sponsors and Collaborators:	Eyetech Pharmaceuticals Pfizer
Information provided by:	Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00354445

Purpose

The purpose of this study is to explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment. Patients must have 1, but not more than 3 prior treatments for Neovascular AMD.

Condition	Intervention	Phase
Age-Related Macular Degeneration (AMD)	Drug: pegaptanib sodium (Macugen)	Phase IV

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Dietary Sodium Macular Degeneration

Drug Information available for: Pegaptanib sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Phase IV, Open Label, Multi-Center, Study of Maintenance Intravitreous Injections of Macugen (Pegaptanib Sodium) Given Every 6 Weeks for 48 Weeks in Subjects With Subfoveal Neovascular Age-Related Macular Degeneration (AMD) Initially Treated With a Modality Resulting in Maculopathy Improvement

Further study details as provided by Eyetech Pharmaceuticals:

Estimated Enrollment:	1000
Study Start Date:	June 2006

Eligibility

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

Criteria

Inclusion Criteria:

Subfoveal CNV secondary to AMD
At least 1 but not more than 3 prior treatments for AMD

Exclusion Criteria:

Subfoveal scar or subfoveal atrophy
Significant media opacities, including cataract, which might interfere with visual acuity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354445

Contacts

Contact: Macugen Information

1-866-622-8436

Locations

United States, Texas
Retina Research Institute of Texas, LLC	Recruiting
Abilene, Texas, United States, 79606
Contact: Macugen Information 866-622-8436

Sponsors and Collaborators

Eyetech Pharmaceuticals

Pfizer

More Information

Study ID Numbers:	EOP1023
Study First Received:	July 18, 2006
Last Updated:	January 12, 2007
ClinicalTrials.gov Identifier:	NCT00354445
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eyetech Pharmaceuticals:

Age-Related Macular Degeneration (AMD)
pegaptanib sodium
subfoveal CNV
macugen

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 14, 2009