Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration

PHASE3CompletedINTERVENTIONAL
Enrollment

485

Participants

Timeline

Start Date

May 12, 2021

Primary Completion Date

July 7, 2022

Study Completion Date

May 10, 2023

Conditions
Neovascular Age-related Macular Degeneration
Interventions
BIOLOGICAL

SOK583A1 (40 mg/mL)

IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.

BIOLOGICAL

Eylea EU (40 mg/mL)

IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.

Trial Locations (102)

1002

Sandoz Investigational Site, Riga

1134

Sandoz Investigational Site, Budapest

1204

Sandoz Investigational Site, Budapest

1784

Sandoz Investigational Site, Sofia

2000

Sandoz Investigational Site, Sydney

2150

Sandoz Investigational Site, Parramatta

2170

Sandoz Investigational Site, Liverpool

2640

Sandoz Investigational Site, Albury

3002

Sandoz Investigational Site, Melbourne

4021

Sandoz Investigational Site, Linz

4032

Sandoz Investigational Site, Debrecen

5000

Sandoz Investigational Site, Adelaide

8022

Sandoz Investigational Site, Barcelona

11021

Sandoz Investigational Site, Great Neck

12808

Sandoz Investigational Site, Prague

13008

Sandoz Investigational Site, Marseille

13088

Sandoz Investigational Site, Liverpool

14620

Sandoz Investigational Site, Rochester

21740

Sandoz Investigational Site, Hagerstown

24502

Sandoz Investigational Site, Lynchburg

30060

Sandoz Investigational Site, Marietta

30625

Sandoz Investigational Site, Hanover

31008

Sandoz Investigational Site, Pamplona

33012

Sandoz Investigational Site, Oviedo

33324

Sandoz Investigational Site, Plantation

33782

Sandoz Investigational Site, Pinellas Park

34994

Sandoz Investigational Site, Stuart

35043

Sandoz Investigational Site, Marburg

37540

Sandoz Investigational Site, Saint-Cyr-sur-Loire

40212

Sandoz Investigational Site, Düsseldorf

44281

Sandoz Investigational Site, Kfar Saba

48006

Sandoz Investigational Site, Bilbao

50009

Sandoz Investigational Site, Zaragoza

50161

Sandoz Investigational Site, Kaunas

55131

Sandoz Investigational Site, Mainz

57701

Sandoz Investigational Site, Rapid City

60452

Sandoz Investigational Site, Oak Forest

60596

Sandoz Investigational Site, Frankfurt am Main

75015

Sandoz Investigational Site, Paris

76012

Sandoz Investigational Site, Arlington

76087

Sandoz Investigational Site, Willow Park

79106

Sandoz Investigational Site, Freiburg im Breisgau

79606

Sandoz Investigational Site, Abilene

83301

Sandoz Investigational Site, Bratislava

85021

Sandoz Investigational Site, Phoenix

87102

Sandoz Investigational Site, Albuquerque

91006

Sandoz Investigational Site, Arcadia

91107

Sandoz Investigational Site, Pasadena

91171

Sandoz Investigational Site, Trenčín

91203

Sandoz Investigational Site, Glendale

91436

Sandoz Investigational Site, Encino

92064

Sandoz Investigational Site, Poway

92374

Sandoz Investigational Site, Redlands

92647

Sandoz Investigational Site, Huntington Beach

92835

Sandoz Investigational Site, Fullerton

95008

Sandoz Investigational Site, Campbell

95841

Sandoz Investigational Site, Sacramento

97401

Sandoz Investigational Site, Eugene

3434104

Sandoz Investigational Site, Haifa

4941492

Sandoz Investigational Site, Petah Tikva

6093000

Sandoz Investigational Site, Lod

6423906

Sandoz Investigational Site, Tel Aviv

7610001

Sandoz Investigational Site, Rehovot

9112001

Sandoz Investigational Site, Jerusalem

33912-7125

Sandoz Investigational Site, Fort Myers

A 4020

Sandoz Investigational Site, Linz

A-8036

Sandoz Investigational Site, Graz

530 02

Sandoz Investigational Site, Pardubice

150 00

Sandoz Investigational Site, Prague

04103

Sandoz Investigational Site, Leipzig

H-1085

Sandoz Investigational Site, Budapest

H-1136

Sandoz Investigational Site, Budapest

H-9400

Sandoz Investigational Site, Sopron

H-6720

Sandoz Investigational Site, Szeged

H-8000

Sandoz Investigational Site, Székesfehérvár

480-1195

Sandoz Investigational Site, Nagakute

457 8510

Sandoz Investigational Site, Nagoya

466 8560

Sandoz Investigational Site, Nagoya

812-8582

Sandoz Investigational Site, Fukuoka

737-0029

Sandoz Investigational Site, Kure

660 8550

Sandoz Investigational Site, Amagasaki

650-0017

Sandoz Investigational Site, Kobe

300-0395

Sandoz Investigational Site, Inashiki-gun

890 8520

Sandoz Investigational Site, Kagoshima

430-8558

Sandoz Investigational Site, Hamamatsu

152-8902

Sandoz Investigational Site, Meguro-ku

111-0051

Sandoz Investigational Site, Taito-ku

755-8505

Sandoz Investigational Site, Ube

LV-1007

Sandoz Investigational Site, Riga

LT-08661

Sandoz Investigational Site, Vilnius

30-394

Sandoz Investigational Site, Krakow

85-631

Sandoz Investigational Site, Bydgoszcz

91-134

Sandoz Investigational Site, Lodz

20-079

Sandoz Investigational Site, Lublin

53-334

Sandoz Investigational Site, Wroclaw

3000-548

Sandoz Investigational Site, Coimbra

3030-363

Sandoz Investigational Site, Coimbra

4200 319

Sandoz Investigational Site, Porto

010 01

Sandoz Investigational Site, Žilina

821 01

Sandoz Investigational Site, Bratislava

08190

Sandoz Investigational Site, Sant Cugat del Vallès

08021

Sandoz Investigational Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sandoz

INDUSTRY

NCT04864834 - Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration | Biotech Hunter | Biotech Hunter