A Clinical Trial to Explore Safety and Efficacy of Different Doses of Pegaptanib Sodium, Compared to Sham, in Patients With Wet AMD.

This study has been completed.

Sponsors and Collaborators:	Eyetech Pharmaceuticals Pfizer
Information provided by:	Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00321997

Purpose

The purpose of this study is to compare the ability of different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or impriving vision in patients with wet AMD when compared to placebo injections.

Condition	Intervention	Phase
Age-Related Macular Degeneration	Drug: Pegaptanib sodium	Phase II Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Bevacizumab Pegaptanib sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A PHASE II/III RANDOMIZED, DOUBLE-MASKED, CONTROLLED, DOSE-RANGING, MULTI-CENTER COMPARATIVE TRIAL, IN PARALLEL GROUPS, TO ESTABLISH THE SAFETY AND EFFICACY OF INTRAVITREAL INJECTIONS OF EYE001 (ANTI-VEGF PEGYLATED APTAMER) GIVEN EVERY 6 WEEKS FOR 54 WEEKS, IN PATIENTS WITH EXUDATIVE AGE-RELATED MACULAR DEGENERATION (AMD)

Further study details as provided by Eyetech Pharmaceuticals:

Estimated Enrollment:	540
Study Start Date:	May 2001
Estimated Study Completion Date:	October 2007

Eligibility

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

Criteria

Inclusion Criteria:

Subjects of either gender, aged 50 years or greater. Subfoveal choroidal neovascularization (CNV) due to AMD. Best corrected visual acuity in the study eye between 20/40 and 20/320.

Exclusion Criteria:

Any prior subfoveal thermal laser therapy.

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	EOP1003 and EOP1004
Study First Received:	May 2, 2006
Last Updated:	May 2, 2006
ClinicalTrials.gov Identifier:	NCT00321997
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eyetech Pharmaceuticals:

AMD
Age-Related Macular Degeneration
Macular Degeneration
Macugen
pegaptanib sodium

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration

Bevacizumab
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 16, 2009