Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement
NCT ID: NCT01783886
Last Updated: 2016-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
381 participants
INTERVENTIONAL
2013-02-28
2015-03-31
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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Intravitreal Aflibercept Injection 2Q4
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
Intravitreal Aflibercept Injection 2Q8
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
Macular Laser Photocoagulation
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
Macular Laser Photocoagulation
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
Interventions
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Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
Macular Laser Photocoagulation
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Subjects with diabetic macular edema (DME) secondary to diabetes mellitus involving the center of the macula in the study eye
* Decrease in vision determined to be primarily the result of DME in the study eye
* Best-corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 73 to 24 (20/40 to 20/320) in the study eye
Exclusion Criteria
* More than 2 previous macular laser treatments in the study eye
* Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
* Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1
* Active proliferative diabetic retinopathy (PDR) in the study eye
* 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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Guangzhou, Guangdong, China
Wuhan, Hubei, China
Changsha, Hunan, China
Shenyang, Liaoning, China
Xi'an, Shaanxi, China
Qingdao, Shandong, China
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Chongqing, , China
Shanghai, , China
Tianjin, , China
Hong Kong, , Hong Kong
Kowloon, , Hong Kong
Moscow, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Saint Petersburg, , Russia
Seoul, , South Korea
Seoul, , South Korea
Countries
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References
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Chen YX, Li XX, Yoon YH, Sun X, Astakhov Y, Xu G, Wang H, Ren X, Asmus F; VIVID-East investigators. Intravitreal Aflibercept versus Laser Photocoagulation in Asian Patients with Diabetic Macular Edema: The VIVID-East Study. Clin Ophthalmol. 2020 Mar 9;14:741-750. doi: 10.2147/OPTH.S235267. eCollection 2020.
Ming J, Zhang Y, Xu X, Zhao M, Wang Y, Chen Y, Zhang F, Wang J, Liu J, Zhao X, Han R, Hu S. Cost-effectiveness analysis of intravitreal aflibercept in the treatment of diabetic macular edema in China. J Comp Eff Res. 2020 Feb;9(3):161-175. doi: 10.2217/cer-2019-0174. Epub 2020 Jan 6.
Other Identifiers
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15161
Identifier Type: -
Identifier Source: org_study_id
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