A Clinical Trial to Explore Safety and Efficacy of Different Doses of Pegaptanib Sodium, Compared to Sham, in Patients With Wet AMD.
This study has been completed.
Sponsor:
Eyetech Pharmaceuticals
Collaborator:
Pfizer
Information provided by:
Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00321997
First received: May 2, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
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Purpose
The purpose of this study is to compare the ability of different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or impriving vision in patients with wet AMD when compared to placebo injections.
| Condition | Intervention | Phase |
|---|---|---|
|
Age-Related Macular Degeneration |
Drug: Pegaptanib sodium |
Phase 2 Phase 3 |
| 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/III RANDOMIZED, DOUBLE-MASKED, CONTROLLED, DOSE-RANGING, MULTI-CENTER COMPARATIVE TRIAL, IN PARALLEL GROUPS, TO ESTABLISH THE SAFETY AND EFFICACY OF INTRAVITREAL INJECTIONS OF EYE001 (ANTI-VEGF PEGYLATED APTAMER) GIVEN EVERY 6 WEEKS FOR 54 WEEKS, IN PATIENTS WITH EXUDATIVE AGE-RELATED MACULAR DEGENERATION (AMD) |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
Drug Information available for:
Pegaptanib sodium
U.S. FDA Resources
Further study details as provided by Eyetech Pharmaceuticals:
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Subjects of either gender, aged 50 years or greater. Subfoveal choroidal neovascularization (CNV) due to AMD. Best corrected visual acuity in the study eye between 20/40 and 20/320.
Exclusion Criteria:
Any prior subfoveal thermal laser therapy.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00321997 History of Changes |
| Other Study ID Numbers: | EOP1003 and EOP1004 |
| Study First Received: | May 2, 2006 |
| Last Updated: | May 2, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eyetech Pharmaceuticals:
|
AMD Age-Related Macular Degeneration Macular Degeneration Macugen pegaptanib sodium |
Additional relevant MeSH terms:
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 19, 2013