Clinical Trial: Pegaptanib Sodium (Macugen) Compared to Sham Injection in Patients with Diabetic Macular Edema (DME) Involving the Center of the Macula

This study is currently recruiting patients.
Verified by Eyetech Pharmaceuticals September 2005

Sponsors and Collaborators: Eyetech Pharmaceuticals
Pfizer
Information provided by: Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00148811

Purpose

The purpose of the study to determine if pegaptanib sodium (Macugen) is safe and effective in slowing down the leakage of fluid within the eye and thereby stabilizing or improving vision when compared to placebo injections.
Condition Intervention Phase
Diabetic Macular Edema
 Drug: pegaptanib sodium (Macugen)
Phase II
Phase III

MedlinePlus related topics:  Diabetic Eye Problems;   Edema;   Vision Impairment and Blindness

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Dose-Finding Trial, in Parallel Groups, to Compare the Safety and Efficacy of Intravitreous Injections of 0.3, 0.03 or 0.003 Mg Pegaptanib Sodium (Macugen), Given as Often as Every 6 Weeks for 3 Years, to Sham Injections in Subjects with Diabetic Macular Edema (DME) Involving the Center of the Macula.

Further Study Details: 

Expected Total Enrollment:  900

Study start: September 2005;  Expected completion: February 2010

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Diabetic macular edema with corresponding leakage on fluorescein angiogram
  • Foveal thickness of at least 300 microns on OCT.
  • Best corrected visual acuity in the study eye between 20/50 and 20/200
  • Women of childbearing potential must use two effective forms of contraception throughout the duration of the study

Exclusion Criteria:

  • Prior or current need for panretinal photocoagulation
  • Prior treatment with an investigational agent for DME

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00148811

Macugen Information      1-866-622-8436 

Texas
      Valley Retina Associates, McAllen,  Texas,  785003,  United States; Recruiting
Macugen Information  866-622-8436 

More Information

Study ID Numbers:  EOP1013
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00148811
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13

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