Pegaptanib Sodium Compared to Sham Injection in Patients With DME Involving the Center of the Macula

This study has been completed.

First Received: June 24, 2002 Last Updated: May 2, 2006 History of Changes

Sponsor:	Eyetech Pharmaceuticals
Information provided by:	Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00040313

Purpose

The purpose of the study is to determine whether pegaptanib sodium (Macugen) is safe and effective in slowing the leakage of fluid within the retina and thereby stabilizing or improving vision when compared to placebo injections. A total of 176 patients will be enrolled

Condition	Intervention	Phase
Diabetic Macular Edema	Drug: pegaptanib sodium (Macugen)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Randomized, Controlled, Double-Masked, Dose-Finding, Multi-Center, Comparative Trial, in Parallel Groups, to Establish the Safety and Preliminary Efficacy of Intravitreal Injections of EYE001 (Anti-VEGF Pegylated Aptamer), Given Every 6 Weeks for 12 to 30 Weeks to Patients With Clinically Significant Diabetic Macular Edema (CSME) Involving the Center of the Macula

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Pegaptanib sodium

U.S. FDA Resources

Further study details as provided by Eyetech Pharmaceuticals:

Estimated Enrollment:	0
Study Start Date:	October 2002
Estimated Study Completion Date:	February 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with clinically significant DME, VA 20/50-20/320 in the study eye and 20/100 in the fellow eye

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	EOP1005
Study First Received:	June 24, 2002
Last Updated:	May 2, 2006
ClinicalTrials.gov Identifier:	NCT00040313 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Signs and Symptoms
Macular Edema
Eye Diseases
Retinal Degeneration

Macular Degeneration
Edema
Retinal Diseases

ClinicalTrials.gov processed this record on November 30, 2009