Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,240

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

September 30, 2010

Study Completion Date

August 31, 2011

Conditions
Macular Degeneration
Interventions
DRUG

Ranibizumab

Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

BIOLOGICAL

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

BIOLOGICAL

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

BIOLOGICAL

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

Trial Locations (189)

1002

Riga

1009

Riga

1050

Riga

1083

Budapest

1090

Vienna

1106

Budapest

1133

Budapest

1211

Geneva

2000

Sydney

2067

Chatswood

2145

Westmead

2150

Parramatta

2333

Leiden

3002

East Melbourne

3010

Bern

3050

Parkville

4000

Liège

4021

Linz

4031

Basel

6009

Nedlands

6020

Innsbruck

8091

Zurich

8200

Veszprém

10034

Prague

10122

Torino

11282

Stockholm

12200

Berlin

13008

Marseille

14000

Prague

15705

Santiago de Compostela

16132

Genova

20122

Milan

20132

Milan

20157

Milan

20251

Hamburg

21079

Dijon

21100

Varese

23538

Lübeck

24105

Kiel

25030

Besançon

28002

Madrid

28046

Madrid

29010

Málaga

31008

Pamplona

31238

Chihuahua City

33000

Bordeaux

33012

Oviedo

33100

Udine

34362

Haifa

35128

Padua

37121

Verona

41009

Seville

41013

Seville

44093

Nantes

45060

Zapopan

45122

Essen

46014

Valencia

46015

Valencia

47005

Valladolid

48145

Münster

49100

Petah Tikva

50924

Cologne

52074

Aachen

52140

Metepec

53105

Bonn

55131

Mainz

58185

Linköping

60126

Ancona

63400

Brno

64060

Monterrey

64239

Tel Aviv

64297

Darmstadt

64480

Monterrey

66421

Homburg

67063

Ludwigshafen am Rhein

69003

Lyon

69006

Lyon

69120

Heidelberg

70124

Bari

70185

Örebro

70300

Zrifin

72076

Tübingen

75010

Paris

75015

Paris

75557

Paris

76100

Rehovot

77520

Olomouc

79106

Freiburg im Breisgau

81369

Bratislava

81675

München

91120

Jerusalem

93053

Regensburg

95123

Catania

97517

Banská Bystrica

110002

New Delhi

110029

New Delhi

119074

Singapore

159964

Singapore

160012

Chandigarh

168751

Singapore

308433

Singapore

380009

Ahemedabad - 4

400031

Wadala, Mumbai

560010

Bangalore

600007

Pondicherry

641014

Coimbatore

683572

Kerala

700073

Kolkata

C1015ABO

Buenos Aires

C1023AAQ

Buenos Aires

C1122AAI

Buenos Aires

C1181ACH

Buenos Aires

X5000IIT

Córdoba

S2000ANJ

Rosario

14048-900

Ribeirão Preto

04023-062

São Paulo

05651-901

São Paulo

30150-270

Minas Gerais

Unknown

Medellín

Bogotá

Cali

Kfar Saba

Afula

Beersheba

Tel Litwinsky

401 13

Ústí nad Labem

01307

Dresden

06067

Dresden

04103

Leipzig

600 006

Chennai

625 020

Madurai

500 034

Hyderabad

400 050

Mumbai

751 024

Orissa

00133

Roma

00168

Roma

00198

Roma

466-8560

Nagoya

467-8602

Nagoya

279-0021

Urayasu

812-8582

Fukuoka

960-1295

Fukushima

371-8511

Maebashi

060-8604

Sapporo

761-0793

Kita

890-8520

Kagoshima

606-8507

Kyoto

573-1191

Hirakata

565-0871

Suita

520-2192

Ōtsu

101-8309

Chiyoda-ku

160-8582

Shinjuku-ku

06800

Mexico City

06030

Mexico City

04030

México D.F.

1100 DD

Amsterdam

9713 GZ

Groningen

6525 EX

Nijmegen

3000 CA

Rotterdam

85-631

Bydgoszcz

80-952

Gdansk

40-760

Katowice

61-848

Poznan

00-416

Warsaw

02-005

Warszaa

50-368

Wroclaw

3000-548

Coimbra

4200-319

Porto

463 707

Seongnam

405-760

Incheon

110 744

Seoul

137 701

Seoul

138-736

Seoul

152-703

Seoul

03016

Alicante

08017

Barcelona

08022

Barcelona

08035

Barcelona

08036

Barcelona

SO16 6YD

Southampton

GU16 5UJ

Camberley

AB25 2ZN

Aberdeen

BT12 6BA

Belfast

B4 7ET

Birmingham

L7 8XP

Liverpool

NW1 5QH

London

SE5 9RS

London

PL4 6PL

Plymouth

TQ2 7AA

Torquay

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Bayer

INDUSTRY

NCT00637377 - Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) | Biotech Hunter | Biotech Hunter