Pegaptanib Sodium Compared to Sham Injection in Patients With DME Involving the Center of the Macula
This study has been completed.
Sponsor:
Eyetech Pharmaceuticals
Information provided by:
Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00040313
First received: June 24, 2002
Last updated: May 2, 2006
Last verified: May 2006
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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:
Genetics Home Reference related topics:
age-related macular degeneration
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:
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
| 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:
|
Edema Macular Edema Signs and Symptoms Macular Degeneration |
Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on June 18, 2013