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A Clinical Trial to Explore Safety and Efficacy of Different Doses of Pegaptanib Sodium, Compared to Sham, in Patients With Wet AMD.

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ClinicalTrials.gov Identifier: NCT00321997
Recruitment Status : Completed
First Posted : May 4, 2006
Last Update Posted : May 4, 2006
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eyetech Pharmaceuticals

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Pegaptanib sodium Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : May 2001
Study Completion Date : October 2007

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00321997    
Other Study ID Numbers: EOP1003 and EOP1004
First Posted: May 4, 2006    Key Record Dates
Last Update Posted: May 4, 2006
Last Verified: May 2006
Keywords provided by Eyetech Pharmaceuticals:
AMD
Age-Related Macular Degeneration
Macular Degeneration
Macugen
pegaptanib sodium
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases