Trial Condition(s):

Macular Edema

Efficacy and safety of VEGF Trap Eye in diabetic macular edema (DME) with central involvement (VIVID EAST)

Bayer Identifier:

15161

ClinicalTrials.gov Identifier:

NCT01783886

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Summary

Enrollment Goal
381
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Peking Union Medical College Hospital

Beijing, China, 100730

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Peking University Third Hospital

Beijing, China, 100083

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Beijing Tongren Hospital, Capital Medical University

Beijing, China, 100730

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Peking University People's Hospital

Beijing, China, 100044

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Eye & Ent Hospital of Fudan University

Shanghai, China

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The Affiliated Eye Hospital of Wenzhou Medical College

Wenzhou, China

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West China Hospital,Sichuan University

Chengdu, China, 610041

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Zhongshan Ophthalmic Center, SUN YAT-SEN University

Guangzhou, China, 510064

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The 1st Affiliated Hosp of the 4th Military Med Uni

Xi'an, China, 710032

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2nd Affiliated Hosp., Zhejiang Univ. College of Medicine

Hangzhou, China, 310009

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2nd Xiangya Hosp., Central South Univ.

Changsha, China, 410011

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Qingdao Eye Hosp.

Qingdao, China

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Tianjin Medical University Eye Center

Tianjin, China

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Shanghai First People's Hospital

Beijing, China, 2000080

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Samsung Medical Center

Seoul, South Korea, 135-710

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Asan Medical Center

Seoul, South Korea, 138-736

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Hong Kong Eye Hospital

Kowloon, Hong Kong, China

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Queen Mary Hospital

Hong Kong, Hong Kong, China

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St. Petersburg Medical University n.a. I.P. Pavlov

St. Petersburg, Russia, 197022

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FBSI IRTC Eye Microsurgery n.a. acad. S.N. Fyodorov

Moscow, Russia, 127486

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Novosibirsk Branch of FBSI IRTC Eye Microsurgery

Novosibirsk, Russia, 630071

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Moscow Scien. Res. Institute of Eye Diseases n.a. Helmholtz

Moscow, Russia, 105062

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TianJin eye hospital

Tianjin, China

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SHENYANG HE EYE HOSPITAL

Shenyang, China, 110034

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Daping Hospital, third military medical university

Chongqing, China, 400042

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Renmin Hosp., Wuhan Univ.

Wuhan, China, 430040

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Beijing Friendship Hospital,Capital Medical University

Beijing, China, 100050

Trial Design