Trial Condition(s):

Retinopathy of prematurity (ROP)

Extension study to evaluate the long-term outcomes of subjects in Study 20090 (FIREFLEYE next)

Bayer Identifier:

20275

ClinicalTrials.gov Identifier:

NCT04015180

EudraCT Number:

2018-003180-54

Recruitment Complete

Trial Purpose

This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.

Inclusion Criteria
- Subject was treated in Study 20090
- Age less than 13 months of chronological age
- Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Exclusion Criteria
- Subject has a condition preventing participation in the study, or performance of study procedures.

Trial Summary

Enrollment Goal
96
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Hacettepe Universitesi Tip Fakultesi

Ankara, Turkey, 06100

Status
Active, not recruiting
 
Locations

Eskisehir Osmangazi Universitesi Tip Fakultesi

Eskisehir, Turkey, 26480

Status
Active, not recruiting
 
Locations

Saglik Bilimleri Universitesi Antalya EA Hastanesi

Antalya, Turkey, 07100

Status
Active, not recruiting
 
Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00168

Status
Active, not recruiting
 
Locations

IRCCS Ospedale Pediatrico Bambino Gesù

Roma, Italy, 00165

Status
Active, not recruiting
 
Locations

A.O. di Perugia

Perugia, Italy, 06129

Status
Active, not recruiting
 
Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Active, not recruiting
 
Locations

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

Adana, Turkey, 4522

Status
Active, not recruiting
 
Locations

Gazi Universitesi Tip Fakultesi

Ankara, Turkey, 06500

Status
Active, not recruiting
 
Locations

Asan Medical Center

Seoul, South Korea, 05505

Status
Active, not recruiting
 
Locations

Soon Chun Hyang University Cheonan Hospital

Cheonan-si, South Korea

Status
Active, not recruiting
 
Locations

Acibadem City Clinic Multiprofile Hospital for Active Treatm

Sofia, Bulgaria, 1407

Status
Active, not recruiting
 
Locations

UMHAT Sveti Georgi

Plovdiv, Bulgaria, 4002

Status
Active, not recruiting
 
Locations

Spec. Hospital of Ophthalm. for Active Treatment Visus

Sofia, Bulgaria, 1619

Status
Active, not recruiting
 
Locations

Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna

Varna, Bulgaria, 9000

Status
Active, not recruiting
 
Locations

Hospital Universitario "La Paz"

Madrid, Spain, 28046

Status
Active, not recruiting
 
Locations

Hospital Regional de Malaga | Oftalmologia

Malaga, Spain, 29010

Status
Active, not recruiting
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Active, not recruiting
 
Locations

Maxima Medisch Centrum, locatie Veldhoven

VELDHOVEN, Netherlands, 5504 DB

Status
Active, not recruiting
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden

Status
Active, not recruiting
 
Locations

Vseobecna fakultni nemocnice v Praze

Praha 2, Czech Republic, 128 08

Status
Active, not recruiting
 
Locations

Fakultni nemocnice Ostrava

Ostrava, Czech Republic, 708 52

Status
Active, not recruiting
 
Locations

UNIFESP/EPM

Sao Paulo, Brazil, 04023-061

Status
Active, not recruiting
 
Locations

Hospital das Clínicas de Botucatu - UNESP Botucatu

Botucatu, Brazil, 18618 970

Status
Active, not recruiting
 
Locations

Narodny ustav detskych chorob

Bratislava, Slovakia, 833 41

Status
Active, not recruiting
 
Locations

The Filatov Institute of Eye Diseases and Tissue Therapy

Odesa, Ukraine, 65061

Status
Active, not recruiting
 
Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, China, 807

Status
Active, not recruiting
 
Locations

Mackay Memorial Hospital

Taipei, Taiwan, China, 10449

Status
Active, not recruiting
 
Locations

P & A KYRIAKOU Children's Hospital

Athens, Greece, 11527

Status
Active, not recruiting
 
Locations

University General Hospital of Ioannina

Ioannina, Greece, 45500

Status
Active, not recruiting
 
Locations

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, Greece, 56403

Status
Active, not recruiting
 
Locations

AZ St-Jan Brugge Oostende AV

BRUGGE, Belgium, 8000

Status
Active, not recruiting
 
Locations

Hospital Prof. Dr. Fernando Fonseca

Amadora, Portugal, 2720-276

Status
Active, not recruiting
 
Locations

Centro Hospitalar de Lisboa Ocidental | Clin Res Dept

Lisboa, Portugal, 1449-005

Status
Active, not recruiting
 
Locations

KK Women's and Children's Hospital

Singapore, Singapore, 229899

Status
Active, not recruiting
 
Locations

EKBC, Uj Szent Janos Korhaz es Szakrendelo

Budapest, Hungary, 1125

Status
Active, not recruiting
 
Locations

Hospital Público Descentralizado "Dr. Guillermo Rawson"

San Juan, Argentina, 5400

Status
Active, not recruiting
 
Locations

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia, 50586

Status
Active, not recruiting
 
Locations

Fukushima Medical University Hospital

Fukushima, Japan, 960-1295

Status
Completed
 
Locations

Tokyo Metropolitan Bokutoh Hospital

Sumida-ku, Japan, 130-8575

Status
Active, not recruiting
 
Locations

Tokyo Metropolitan Ohtsuka Hospital

Toshima-ku, Japan, 170-8476

Status
Active, not recruiting
 
Locations

Tokyo Metropolitan Children's Medical Center

Fuchu, Japan, 183-8561

Status
Active, not recruiting
 
Locations

Kindai University Hospital

Osakasayama, Japan, 589-8511

Status
Active, not recruiting
 
Locations

Fukuoka University Hospital

Fukuoka, Japan, 814-0180

Status
Active, not recruiting
 
Locations

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Status
Active, not recruiting
 
Locations

Kurume University Hospital

Kurume, Japan, 830-0011

Status
Active, not recruiting
 
Locations

University of Occupational and Environmental Health

Kitakyushu, Japan, 807-8556

Status
Active, not recruiting
 
Locations

Okinawa Prefectural Nanbu Medical Center and Children's MC

Shimajiri-gun, Japan, 901-1193

Status
Active, not recruiting
 
Locations

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

Moscow, Russia, 119620

Status
Active, not recruiting
 
Locations

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

Kaluga, Russia, 248007

Status
Active, not recruiting
 
Locations

City Children Hospital ¿1

Saint-Petersburg, Russia, 198205

Status
Active, not recruiting
 
Locations

Kaplan Medical Center

Rehovot, Israel, 7661041

Status
Active, not recruiting
 
Locations

Birmingham Womens Hospital

Birmingham, United Kingdom, B15 2TG

Status
Active, not recruiting
 
Locations

Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda"

Iasi, Romania, 700038

Status
Active, not recruiting
 
Locations

Clinical Emergency County Hospital

Cluj-Napoca, Romania, 400006

Status
Active, not recruiting
 

Trial Design