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
Status
LocationsStatus
Locations

Peking Union Medical College Hospital

Beijing, China, 100730

Status
Completed
Locations

Peking University Third Hospital

Beijing, China, 100083

Status
Terminated
Locations

Beijing Tongren Hospital, Capital Medical University

Beijing, China, 100730

Status
Completed
Locations

Peking University People's Hospital

Beijing, China, 100044

Status
Completed
Locations

Eye & Ent Hospital of Fudan University

Shanghai, China

Status
Completed
Locations

The Affiliated Eye Hospital of Wenzhou Medical College

Wenzhou, China

Status
Completed
Locations

West China Hospital,Sichuan University

Chengdu, China, 610041

Status
Completed
Locations

Zhongshan Ophthalmic Center, SUN YAT-SEN University

Guangzhou, China, 510064

Status
Completed
Locations

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

Xi'an, China, 710032

Status
Completed
Locations

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

Hangzhou, China, 310009

Status
Completed
Locations

2nd Xiangya Hosp., Central South Univ.

Changsha, China, 410011

Status
Completed
Locations

Qingdao Eye Hosp.

Qingdao, China

Status
Completed
Locations

Tianjin Medical University Eye Center

Tianjin, China

Status
Completed
Locations

Shanghai First People's Hospital

Beijing, China, 2000080

Status
Completed
Locations

Samsung Medical Center

Seoul, South Korea, 135-710

Status
Completed
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
Locations

Hong Kong Eye Hospital

Kowloon, Hong Kong, China

Status
Completed
Locations

Queen Mary Hospital

Hong Kong, Hong Kong, China

Status
Completed
Locations

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

St. Petersburg, Russia, 197022

Status
Completed
Locations

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

Moscow, Russia, 127486

Status
Completed
Locations

Novosibirsk Branch of FBSI IRTC Eye Microsurgery

Novosibirsk, Russia, 630071

Status
Completed
Locations

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

Moscow, Russia, 105062

Status
Terminated
Locations

TianJin eye hospital

Tianjin, China

Status
Completed
Locations

SHENYANG HE EYE HOSPITAL

Shenyang, China, 110034

Status
Completed
Locations

Daping Hospital, third military medical university

Chongqing, China, 400042

Status
Completed
Locations

Renmin Hosp., Wuhan Univ.

Wuhan, China, 430040

Status
Completed
Locations

Beijing Friendship Hospital,Capital Medical University

Beijing, China, 100050

Status
Completed

Trial Design