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Sponsors and Collaborators: |
Pfizer Monitoring : ITEC GROUP 3, avenue Georges Clemenceau 33150 Cenon Bordeaux France |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00324116 |
To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal neovascularization.
Condition | Intervention | Phase |
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Macular Degeneration |
Procedure: Color fundus photography Procedure: Fluorescein angiography Drug: pegaptanib sodium (Macugen) Procedure: IOP Procedure: Indocyanine green angiography Procedure: Laboratory tests Procedure: NEI-VFQ 25 questionnaire Procedure: OCT Procedure: Visual acuity |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Open-Label Multi Center Trial Evaluating The Safety And Efficacy Of 0.3 Mg/Eye Pegaptanib Sodium (Macugen) Intravitreous Injection Given Every 6 Weeks For 54 Weeks In Patients With Small Neovascular Age-Related Macular Degeneration (AMD) Lesions |
Enrollment: | 79 |
Study Start Date: | July 2006 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Procedure
Other intervention - no drug.
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Procedure: Color fundus photography
baseline, week 12, 30 and 54.
Procedure: Fluorescein angiography
baseline, week 12, 30 and 54.
Procedure: IOP
every 6 weeks before and after injection of macugen
Procedure: Indocyanine green angiography
baseline, week 12, 30 and 54.
Procedure: Laboratory tests
at baseline
Procedure: NEI-VFQ 25 questionnaire
baseline and week 54
Procedure: OCT
baseline and every 6 weeks
Procedure: Visual acuity
every 6 weeks before injection of macugen
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Active: Experimental |
Drug: pegaptanib sodium (Macugen)
0.3 MG/EYE PEGAPTANIB SODIUM by INTRAVITREOUS INJECTION GIVEN EVERY 6 WEEKS FOR 54 WEEKS
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Pfizer Investigational Site | |
MULHOUSE Cedex 1, France, 68070 | |
Pfizer Investigational Site | |
Bayonne, France, 64100 | |
Pfizer Investigational Site | |
Bordeaux, France, 33076 | |
Pfizer Investigational Site | |
Paris, France, 75015 | |
Pfizer Investigational Site | |
Paris cedex 12, France, 75557 | |
Pfizer Investigational Site | |
DIJON Cedex, France, 21033 | |
Pfizer Investigational Site | |
PARIS Cedex 19, France, 75940 | |
Pfizer Investigational Site | |
Strasbourg, France, 67000 | |
Pfizer Investigational Site | |
Nancy, France, 54000 | |
Pfizer Investigational Site | |
Paris, France, 75006 | |
Pfizer Investigational Site | |
La Tronche, France, 38700 | |
Pfizer Investigational Site | |
Bordeaux, France, 33100 | |
Pfizer Investigational Site | |
La Rochefoucauld, France, 16110 | |
Pfizer Investigational Site | |
Limoges Cedex 1, France, 87042 | |
Pfizer Investigational Site | |
Toulouse, France, 31054 | |
Pfizer Investigational Site | |
Brest, France, 29200 | |
Pfizer Investigational Site | |
Strasbourg Cedex, France, 67091 | |
Pfizer Investigational Site | |
Marseille, France, 13008 | |
Pfizer Investigational Site | |
Montpellier, France, 34000 | |
Pfizer Investigational Site | |
Montpellier, France, 34070 | |
Pfizer Investigational Site | |
Nantes Cedex 1, France, 44093 | |
Pfizer Investigational Site | |
Rives, France, 38140 | |
Pfizer Investigational Site | |
Toulouse, France, 31200 | |
Pfizer Investigational Site | |
Saint-Herblain, France, 44819 | |
Pfizer Investigational Site | |
Rouen, France, 76000 | |
Pfizer Investigational Site | |
Lyon, France, 69003 | |
Pfizer Investigational Site | |
Belfort Cedex, France, 90016 | |
Pfizer Investigational Site | |
Lille, France, 59800 | |
France, Cedex | |
Pfizer Investigational Site | |
Creteil, Cedex, France, 94010 | |
Pfizer Investigational Site | |
Besancon, Cedex, France, 25030 | |
Pfizer Investigational Site | |
Poitiers, Cedex, France, 86021 | |
Pfizer Investigational Site | |
Macon, Cedex, France, 71018 | |
France, Cedex 09 | |
Pfizer Investigational Site | |
Angers, Cedex 09, France, 49933 | |
France, Cedex 4 | |
Pfizer Investigational Site | |
Lyon, Cedex 4, France, 69317 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A5751016 |
Study First Received: | May 8, 2006 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00324116 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases Retinal degeneration |