Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

September 25, 2019

Primary Completion Date

February 12, 2021

Study Completion Date

February 12, 2021

Conditions
Retinopathy of Prematurity (ROP)
Interventions
DRUG

Eylea (Aflibercept, BAY86-5321)

Solution in a sterile glass vial, Dose A, IVT injection.

PROCEDURE

Laser photocoagulation

Transpupillary conventional laser ablative therapy

Trial Locations (90)

1125

EKBC, Uj Szent Janos Korhaz es Szakrendelo, Budapest

1407

Acibadem City Clinic Multiprofile Hospital for Active Treatm, Sofia

1504

II SOGHAT Sheinovo, Sofia

4002

UMHAT Sveti Georgi, Plovdiv

4021

Kepler Universitätsklinikum Campus III, Linz

4522

S.B.U. Adana Sehir Egitim ve Arastirma Hastanesi, Adana

5400

"Hospital Público Descentralizado Dr. Guillermo Rawson", San Juan

8000

AZ St-Jan Brugge Oostende AV, Bruges

9000

SHOGAT Prof Dimitar Stamatov, Varna

10449

Mackay Memorial Hospital, Taipei

11527

P & A KYRIAKOU Children's Hospital, Athens

12808

Vseobecna fakultni nemocnice v Praze, Prague

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

26480

Eskisehir Osmangazi Universitesi Tip Fakultesi, Eskişehir

28041

Hospital Universitario 12 de Octubre, Madrid

28046

"Hospital Universitario La Paz", Madrid

29011

Hospital Regional de Málaga, Málaga

45500

University General Hospital of Ioannina, Ioannina

50586

Hospital Kuala Lumpur, Kuala Lumpur

56403

Papageorgiou General Hospital of Thessaloniki, Thessaloniki

65031

"MIOdesa Regional Children's Clinical Hospital", Odesa

80756

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

117997

Russian National Scientific Medical University, Moscow

119620

"FGBUZ NPC of special children care n.a. Voino-Yaseneckogo", Moscow

194100

Pediatric Medical University, Saint Petersburg

198205

City Children Hospital ¿1, Saint Petersburg

229899

KK Women's and Children's Hospital, Singapore

248007

"FSAI NMRC IRTC Eye Microsurgery, Kaluga's Branch", Kaluga

400006

Clinical Emergency County Hospital, Cluj-Napoca

700038

"Spitalul Clinic de Obstretica si Ginecologie Cuza Voda", Iași

7661041

Kaplan Medical Center, Rehovot

Unknown

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Queen Mary Hospital, Hong Kong

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Soon Chun Hyang University Cheonan Hospital, Cheonan-si

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Sahlgrenska Universitetssjukhuset, Gothenburg

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

Many Locations, Multiple Locations

18618 970

Hospital das Clínicas de Botucatu - UNESP Botucatu, Botucatu

04023-061

Unifesp/Epm, São Paulo

708 52

Fakultni nemocnice Ostrava, Ostrava

00165

IRCCS Ospedale Pediatrico Bambino Gesù, Rome

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

06129

A.O. di Perugia, Perugia

807-8556

University of Occupational and Environmental Health, Kitakyushu

830-0011

Kurume University Hospital, Kurume

901-1193

Okinawa Prefectural Nanbu Medical Center and Children's MC, Shimajiri-gun

183-8561

Tokyo Metropolitan Children's Medical Center, Fuchū

142-8666

Showa University Hospital, Shinagawa

130-8575

Tokyo Metropolitan Bokutoh Hospital, Sumida-ku

170-8476

Tokyo Metropolitan Ohtsuka Hospital, Toshima-ku

812-8582

Kyushu University Hospital, Fukuoka

814-0180

Fukuoka University Hospital, Fukuoka

960-1295

Fukushima Medical University Hospital, Fukushima

330-8777

Saitama Children's Medical Center, Saitama

5504 DB

Maxima Medisch Centrum, locatie Veldhoven, Veldhoven

60-535

Ginekologiczno-Polozniczy SK UM im. K. Marcinkowskiego, Poznan

2720-276

Hospital Prof. Dr. Fernando Fonseca, Amadora

1449-005

CHLO - Hospital Sao Francisco Xavier, Lisbon

833 41

Narodny ustav detskych chorob, Bratislava

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06100

Hacettepe Universitesi Tip Fakultesi, Ankara

06490

Baskent Universitesi Tip Fakultesi Hastanesi, Ankara

06500

Gazi Universitesi Tip Fakultesi, Ankara

07100

Saglik Bilimleri Universitesi Antalya EA Hastanesi, Antalya

B15 2TG

Birmingham Womens Hospital, Birmingham

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Bayer

INDUSTRY