Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)
NCT ID: NCT01512966
Last Updated: 2014-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
73 participants
INTERVENTIONAL
2012-01-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VTE 2Q4 first, then VTE 2Q8
VEGF Trap-Eye \[BAY86-5321; EYLEA (aflibercept) Injection\] 2 mg Q4 (VTE 2Q4) administered every 4 weeks from Week 0 to Week 16, followed by every 8 weeks until Week 48 (2Q8)
VEGF Trap-Eye (BAY86-5321)
Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks.
Interventions
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VEGF Trap-Eye (BAY86-5321)
Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks.
Eligibility Criteria
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Inclusion Criteria
* Subjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye
* BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 24 (20/40 to 20/320) in the study eye
Exclusion Criteria
* Uncontrolled diabetes mellitus, as defined by HbA1c \>12%
* Only 1 functional eye even if that eye is otherwise eligible for the study
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Matsuyama, Ehime, Japan
Maebashi, Gunma, Japan
Kobe, Hyōgo, Japan
Mito, Ibaraki, Japan
Kita, Kagawa-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Kawasaki, Kanagawa, Japan
Kyoto, Kyoto, Japan
Sendai, Miyagi, Japan
Kashihara, Nara, Japan
Okayama, Okayama-ken, Japan
Osaka, Osaka, Japan
Osaka, Osaka, Japan
Suita, Osaka, Japan
Saga, Saga-ken, Japan
Ōtsu, Shiga, Japan
Shimotsuke, Tochigi, Japan
Wakayama, Wakayama, Japan
Countries
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Other Identifiers
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15657
Identifier Type: -
Identifier Source: org_study_id
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