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

This study has been completed.
Sponsor:
Information provided by:
Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00040313
First received: June 24, 2002
Last updated: May 2, 2006
Last verified: May 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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

Additional relevant MeSH terms:
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 21, 2014