A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema
NCT ID: NCT01100307
Last Updated: 2013-08-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
243 participants
INTERVENTIONAL
2010-05-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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pegaptanib sodium
pegaptanib sodium
Intravitreal injection of 0.3 mg every 6 weeks
sham injection
sham injection
sham injection every 6 weeks
Interventions
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pegaptanib sodium
Intravitreal injection of 0.3 mg every 6 weeks
sham injection
sham injection every 6 weeks
Eligibility Criteria
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Inclusion Criteria
* Subjects must have macular edema that involves the center field of the macula 3. Foveal thickness of at least 250 μm 4. Best corrected distance visual acuity in the study eye must be a letter score between 68 and 35 inclusive
Exclusion Criteria
* HbA1C level \>12% or recent signs of uncontrolled diabetes
* Atrophy/scarring/fibrosis involving the center of the macula, including evidence of laser treated atrophy
20 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Akita University Hospital
Akita, Akita, Japan
Aomori Prefectural Chuo Hospital
Aomori, Aomori, Japan
Chiba University Hospital
Chiba, Chiba, Japan
Juntendo University Hospital Urayasu, Ophthalmology
Urayasu-shi, Chiba, Japan
Hayashi Eye Hospital
Fukuoka, Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Murakami Karindo Hospital
Fukuoka, Fukuoka, Japan
Ohshima Hospital of Ophthalmology
Fukuoka, Fukuoka, Japan
St. Mary's Hospital
Kurume, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Kimura Eye & Internal Medicine Hospital
Kure, Hiroshima, Japan
Asahikawa Medical College Hospital
Asahikawa, Hokkaido, Japan
Yoshida Eye Hospital
Hakodate, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Hyogo Prefectural Amagasaki Hospital
Amagasaki, Hyōgo, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Kohnan Hospital
Kobe, Hyōgo, Japan
Hitachi General Hospital
Hitachi, Ibaraki, Japan
Mito Kyodo General Hospital
Mito, Ibaraki, Japan
Kagawa University Hospital
Kida-gun, Kagawa-ken, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan
Ideta eye hospital
Kumamoto, Kumamoto, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
NTT East Tohoku Hospital
Sendai, Miyagi, Japan
Shinshu University Hospital
Matsumoto, Nagano, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan
Osaka City University Hospital
Osaka, Osaka, Japan
Osaka general medical center
Osaka, Osaka, Japan
Osaka Saiseikai Izou Hospital
Osaka, Osaka, Japan
Kinki University Hospital, Anesthesiology
Osaka-sayama-shi, Osaka, Japan
Saga Prefectural Hospital Koseikan
Saga, Saga-ken, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Nihon University Surugadai Hospital
Chiyoda-ku, Tokyo, Japan
Ochanomizu Inoue Eye Clinic
Chiyoda-ku, Tokyo, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Hirota Eye Clinic
Shūnan, Yamaguchi, Japan
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A5751034
Identifier Type: -
Identifier Source: org_study_id