Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement
VIVID EAST
A Randomized, Double Masked, Active Controlled, Phase III Study of the Efficacy and Safety of Repeated Doses of Intravitreal VEGF Trap Eye in Subjects With Diabetic Macular Edema
1 other identifier
interventional
381
4 countries
25
Brief Summary
To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2013
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedFirst Posted
Study publicly available on registry
February 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
April 5, 2016
CompletedMay 12, 2016
April 1, 2016
2.1 years
February 1, 2013
March 6, 2016
April 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)
Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. LOCF censored measurements after additional treatment.
Baseline up to week 52
Secondary Outcomes (6)
Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
Baseline up to week 52
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
Baseline up to week 52
Percentage of Participants With a Greater Than Equal (>=) Two-step Improvement From Baseline in the ETDRS Diabetic Retinopathy Severity Score (DRSS) as Assessed by Fundus Photography (FP) at Week 52 - LOCF
Baseline up to week 52
Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF
Baseline up to week 52
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF
Baseline up to week 52
- +1 more secondary outcomes
Study Arms (3)
Intravitreal Aflibercept Injection 2Q4
EXPERIMENTALParticipants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
Intravitreal Aflibercept Injection 2Q8
EXPERIMENTALParticipants 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.
Macular Laser Photocoagulation
ACTIVE COMPARATORParticipants 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.
Interventions
Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
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
You may qualify if:
- Adults ≥ 18 years with type 1 or 2 diabetes mellitus
- 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
You may not qualify if:
- Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Regeneron Pharmaceuticalscollaborator
Study Sites (25)
Unknown Facility
Guangzhou, Guangdong, 510064, China
Unknown Facility
Wuhan, Hubei, 430040, China
Unknown Facility
Changsha, Hunan, 410011, China
Unknown Facility
Shenyang, Liaoning, 110034, China
Unknown Facility
Xi'an, Shaanxi, 710032, China
Unknown Facility
Qingdao, Shandong, China
Unknown Facility
Chengdu, Sichuan, 610041, China
Unknown Facility
Hangzhou, Zhejiang, 310009, China
Unknown Facility
Wenzhou, Zhejiang, China
Unknown Facility
Beijing, 100044, China
Unknown Facility
Beijing, 100050, China
Unknown Facility
Beijing, 100083, China
Unknown Facility
Beijing, 100730, China
Unknown Facility
Beijing, 2000080, China
Unknown Facility
Chongqing, 400042, China
Unknown Facility
Shanghai, China
Unknown Facility
Tianjin, China
Unknown Facility
Hong Kong, Hong Kong
Unknown Facility
Kowloon, Hong Kong
Unknown Facility
Moscow, 105062, Russia
Unknown Facility
Moscow, 127486, Russia
Unknown Facility
Novosibirsk, 630071, Russia
Unknown Facility
Saint Petersburg, 197022, Russia
Unknown Facility
Seoul, 135-710, South Korea
Unknown Facility
Seoul, 138-736, South Korea
Related Publications (2)
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.
PMID: 32210527DERIVEDMing 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.
PMID: 31904267DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2013
First Posted
February 5, 2013
Study Start
February 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
May 12, 2016
Results First Posted
April 5, 2016
Record last verified: 2016-04