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

Tracking Information
First Received Date ^ICMJE	June 24, 2002
Last Updated Date	May 2, 2006
Start Date ^ICMJE	October 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00040313 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Pegaptanib Sodium Compared to Sham Injection in Patients With DME Involving the Center of the Macula
Official Title ^ICMJE	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
Brief Summary	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
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Diabetic Macular Edema
Intervention ^ICMJE	Drug: pegaptanib sodium (Macugen)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	0
Completion Date	February 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with clinically significant DME, VA 20/50-20/320 in the study eye and 20/100 in the fellow eye
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00040313
Responsible Party
Study ID Numbers ^ICMJE	EOP1005
Study Sponsor ^ICMJE	Eyetech Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eyetech Pharmaceuticals
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP