Intravitreal Aflibercept Injection in Vision Impairment Due to DME

PHASE3CompletedINTERVENTIONAL
Enrollment

406

Participants

Timeline

Start Date

May 9, 2011

Primary Completion Date

June 3, 2013

Study Completion Date

March 30, 2015

Conditions
Diabetes MellitusMacular Edema
Interventions
BIOLOGICAL

VEGF Trap-Eye (BAY86-5321)

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

BIOLOGICAL

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 (Control)

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 (73)

1083

Budapest

1090

Vienna

1106

Budapest

1133

Budapest

2000

Sydney

2145

Westmead

2150

Parramatta

2600

Glostrup Municipality

3002

East Melbourne

4020

Linz

4021

Linz

4032

Debrecen

6009

Nedlands

8000

Århus C

8036

Barcelona

8200

Veszprém

12203

Berlin

15706

Santiago de Compostela

20122

IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico, Milan

20157

Milan

24105

Kiel

31008

Pamplona

33012

Oviedo

33076

Bordeaux

35128

Padua

37075

Göttingen

44093

Nantes

46015

Valencia

50924

Cologne

52074

Aachen

53105

Bonn

55131

Mainz

60126

Ancona

64297

Darmstadt

67063

Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Ludwigshafen am Rhein

69003

Lyon

69120

Heidelberg

72076

Tübingen

75010

Hopital Lariboisiere, Paris

75015

Paris

79106

Freiburg im Breisgau

81675

München

94010

Créteil

500 05

Faculty Hospital Hradec Kralove, Hradec Králové

779 00

Olomouc

708 52

Ostrava

100 34

Prague

H-8900

Zalaegerszeg

00133

Rome

00198

Rome

466-8560

Nagoya

467-8602

Nagoya

078-8510

Asahikwa

060-8648

Sapporo

216-8511

Kawasaki

980-8574

Sendai

390-8621

Matsumoto

573-1191

Hirakata

101-8309

Chiyoda-ku

173-8606

Itabashi-ku

181-8611

Mitaka

162-8666

Shinjuku-ku

010-8543

Akita

260-8677

Chiba

812-8582

Fukuoka

852-8501

Nagasaki

545-8586

Osaka

641-8510

Wakayama

41-902

Bytom

50-556

Wroclaw

51-124

Wroclaw

08190

San Cugat Del Vallès

03016

Alicante

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Bayer

INDUSTRY