Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)

PHASE3CompletedINTERVENTIONAL
Enrollment

355

Participants

Timeline

Start Date

August 23, 2018

Primary Completion Date

November 10, 2020

Study Completion Date

September 10, 2021

Conditions
Diabetic Macular Edema
Interventions
DRUG

MYL-1701P

"Subjects will receive intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks.~The additional doses may be administered in accordance with the protocol."

DRUG

Eylea

"Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks.~The additional doses may be administered in accordance with the protocol."

Trial Locations (73)

1076

Mylan Investigator Site, Budapest

1106

Mylan Investigator Site, Budapest

4032

Mylan Investigator Site, Debrecen

4400

Mylan Investigator Site, Nyíregyháza

6720

Mylan Investigator Site, Szeged

7621

Mylan Investigator Site, Pécs

8900

Mylan Investigator Site, Zalaegerszeg

10034

Mylan Investigator Site, Prague

10424

Mylan Investigator Site, Olsztyn

12808

Mylan Investigator Site, Prague

15000

Mylan Investigator Site, Prague

20815

Mylan Investigator Site, Chevy Chase

26506

Mylan Investigator Site, Morgantown

29456

Mylan Investigator Site, Ladson

30909

Mylan Investigator Site, Augusta

33100

Mylan Investigator Site, Tarnów

33711

Mylan Investigator Site, St. Petersburg

33880

Mylan Investigator Site, Winter Haven

35017

Mylan Investigator Site, Rzeszów

35043

Mylan Investigator Site, Marburg

37075

Mylan Investigator Site, Göttingen

37203

Mylan Investigator Site, Nashville

40594

Mylan Investigator Site, Katowice

42001

Mylan Investigator Site, Paducah

50005

Mylan Investigator Site, Hradec Králové

53002

Mylan Investigator Site, Pardubice

55131

Mylan Investigator Site, Mainz

58309

Mylan Investigator Site, Wałbrzych

66204

Mylan Investigator Site, Shawnee Mission

76275

Mylan Investigator Site, Zlín

77900

Mylan Investigator Site, Olomouc

79606

Mylan Investigator Site, Abilene

85014

Mylan Investigator Site, Phoenix

85020

Mylan Investigator Site, Phoenix

91134

Mylan Investigator Site, Lodz

95841

Mylan Investigator Site, Sacramento

110029

Mylan Investigator Site, New Delhi

119021

Mylan Investigator Site, Moscow

160012

Mylan Investigator Site, Chandigarh

197022

Mylan Investigator Site, Saint Petersburg

201301

Mylan Investigator Site, Noida

302015

Mylan Investigator Site, Jaipur

380015

Mylan Investigator Site, Ahmedabad

380016

Mylan Investigator Site, Ahmedabad

400050

Mylan Investigator Site, Mumbai

420012

Mylan Investigator Site, Kazan'

500034

Mylan Investigator Site, Hyderabad

530040

Mylan Investigator Site, Visakhapatnam

560010

Mylan Investigator Site, Bangalore

560037

Mylan Investigator site, Bangalore

560094

Mylan Investigator Site, Bangalore

625020

Mylan Investigator Site, Madurai

627002

Mylan Investigator Site, Tirunelveli

630096

Mylan Investigator Site, Novosibirsk

644042

Mylan Investigator Site, Omsk

751024

Mylan Investigator Site, Bhubaneswar

2420001

Mylan Investigator Site, Yamato

3100845

Mylan Investigator Site, Mito

3308553

Mylan Investigator Site, Saitama

4008506

Mylan Investigator Site, Kofu

4101102

Mylan Investigator Site, Susono

4578510

Mylan Investigator Site, Nagoya

5400006

National Hospital Organization Osaka National Hospital, Osaka

8110213

Mylan Investigator Site, Fukuoka

8528501

Mylan Investigator Site, Nagasaki

8600027

Mylan Investigator Site, Kumamoto

8920824

Mylan Investigator Site, Kagoshima

9601295

Mylan Investigator Site, Fukushima

9638052

Mylan Investigator Site, Kōriyama

0608604

Mylan Investigator Site, Sapporo

LV-3001

Mylan Investigator Site, Jelgava

LV-1002

Mylan Investigator Site, Riga

LV-1006

Mylan Investigator Site, Riga

Sponsors
All Listed Sponsors
collaborator

Momenta Pharmaceuticals, Inc.

INDUSTRY

lead

Mylan Pharmaceuticals Inc

INDUSTRY