A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration
NCT ID: NCT02181504
Last Updated: 2017-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2014-09-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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abicipar pegol 2 mg
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.
sham procedure
Sham procedure to the study eye at weeks 12 and 16.
abicipar pegol 1 mg
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.
sham procedure
Sham procedure to the study eye at weeks 12 and 16.
ranibizumab 0.5 mg
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
ranibizumab
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Interventions
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abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.
ranibizumab
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
sham procedure
Sham procedure to the study eye at weeks 12 and 16.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of wet age-related macular degeneration in at least 1 eye
* Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye
Exclusion Criteria
* Cataract or refractive surgery within the last 3 months
* History of vitrectomy
50 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Nihon University Hospital
Chiyoda-ku,Tokyo, , Japan
1 Fukushima Medical University
Fukushima, , Japan
Kyushu University Hospital
Kita-ku, Fukuoka-shi Fukuoka, , Japan
Okayama University Hospital
Kita-ku, Okayama-shi Okayama, , Japan
Shiga University
Ōtsu, , Japan
Tokyo Women's Medical University
Shinjuku-ku, , Japan
Nagoya University Hospital
Showa-ku, Nagoya-shi Aichi, , Japan
Takeuchi Eye Clinic
Taito Ku Tokyo, , Japan
Musashi Dream Clinic
Tennoji-ku Osaka, , Japan
Juntendo University Urayas
Urayasu-shi, , Japan
Otakeganka Tsukimino Clinic
Yamato Kanagawa, , Japan
Countries
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Other Identifiers
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BAMBOO
Identifier Type: OTHER
Identifier Source: secondary_id
150998-002
Identifier Type: -
Identifier Source: org_study_id
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