Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement

PHASE3CompletedINTERVENTIONAL
Enrollment

381

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Macular Edema
Interventions
BIOLOGICAL

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).

BIOLOGICAL

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).

PROCEDURE

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.

Trial Locations (25)

100044

Beijing

100050

Beijing

100083

Beijing

100730

Beijing

105062

Moscow

110034

Shenyang

127486

Moscow

197022

Saint Petersburg

310009

Hangzhou

400042

Chongqing

410011

Changsha

430040

Wuhan

510064

Guangzhou

610041

Chengdu

630071

Novosibirsk

710032

Xi'an

2000080

Beijing

Unknown

Qingdao

Wenzhou

Shanghai

Tianjin

Hong Kong

Kowloon

135-710

Seoul

138-736

Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Bayer

INDUSTRY

NCT01783886 - Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement | Biotech Hunter | Biotech Hunter