Trial Condition(s):

Retinopathy of prematurity (ROP)

Aflibercept for retinopathy of prematurity – intravitreal injection versus laser therapy (FIREFLEYE)

Bayer Identifier:

20090

ClinicalTrials.gov Identifier:

NCT04004208

EudraCT Number:

2018-002611-99

Study Completed

Trial Purpose

The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.

Inclusion Criteria
- Gestational age at birth ≤ 32 weeks or birth weight ≤ 1500 g
- Subjects with treatment-naïve ROP classified according to the International Classification for ROP in at least one eye as:
-- Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or
-- Zone II Stage 2 plus or 3 plus, or
-- Aggressive posterior retinopathy of prematurity (AP-ROP)
- Weight at baseline (day of treatment) ≥ 800 g
- 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
- Known or suspected chromosomal abnormality, genetic disorder or syndrome
- Previous exposure to any IVT or systemic anti-vascular endothelial growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during breastfeeding
- Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic nerve function, severe hydrocephalus with significantly increased intracranial
pressure)
- Pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a NICU specialist and a study ophthalmologist
- Presence of active ocular infection within 5 days of the first treatment
- Advanced stages of ROP with partial or complete retinal detachment (ROP Stages 4 and 5)
- ROP involving only Zone III
- Ocular abnormalities that may interfere with the administration of study intervention or assessment of the study primary endpoint
- Postnatal treatment with oral or intravenous corticosteroids at an equivalent dose of prednisone ≥ 1 mg/kg/day for > 2 weeks within 14 days of the first study intervention
- Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative laser therapy, cryotherapy, and vitrectomy)
- Participation of the subject or the mother in other clinical trials requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening, or within 30 days or 5 half-lives of administration of the previous study drug, whichever is longer

Trial Summary

Enrollment Goal
113
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
Completed
 
Locations

Baskent Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey, 06490

Status
Completed
 
Locations

Eskisehir Osmangazi Universitesi Tip Fakultesi

Eskisehir, Turkey, 26480

Status
Completed
 
Locations

Saglik Bilimleri Universitesi Antalya EA Hastanesi

Antalya, Turkey, 07100

Status
Completed
 
Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00168

Status
Completed
 
Locations

IRCCS Ospedale Pediatrico Bambino Gesù

Roma, Italy, 00165

Status
Completed
 
Locations

A.O. di Perugia

Perugia, Italy, 06129

Status
Completed
 
Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Completed
 
Locations

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

Adana, Turkey, 4522

Status
Completed
 
Locations

Gazi Universitesi Tip Fakultesi

Ankara, Turkey, 06500

Status
Completed
 
Locations

Hospital Regional de Málaga

Málaga, Spain, 29011

Status
Completed
 
Locations

Kepler Universitätsklinikum Campus III

Linz, Austria, 4021

Status
Completed
 
Locations

Samsung Medical Center

Seoul, South Korea, 06351

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 05505

Status
Completed
 
Locations

Soon Chun Hyang University Cheonan Hospital

Cheonan-si, South Korea

Status
Completed
 
Locations

Queen Mary Hospital

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

Kaplan Medical Center

Rehovot, Israel, 7661041

Status
Completed
 
Locations

Acibadem City Clinic Multiprofile Hospital for Active Treatm

Sofia, Bulgaria, 1407

Status
Completed
 
Locations

UMHAT Sveti Georgi

Plovdiv, Bulgaria, 4002

Status
Completed
 
Locations

II SOGHAT Sheinovo

Sofia, Bulgaria, 1504

Status
Completed
 
Locations

SHOGAT Prof Dimitar Stamatov

Varna, Bulgaria, 9000

Status
Completed
 
Locations

Hospital Prof. Dr. Fernando Fonseca

Amadora, Portugal, 2720-276

Status
Completed
 
Locations

CHLO - Hospital Sao Francisco Xavier

Lisboa, Portugal, 1449-005

Status
Completed
 
Locations

Hospital Universitario "La Paz"

Madrid, Spain, 28046

Status
Completed
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
 
Locations

AZ St-Jan Brugge Oostende AV

BRUGGE, Belgium, 8000

Status
Completed
 
Locations

Vseobecna fakultni nemocnice v Praze

Praha 2, Czech Republic, 12808

Status
Completed
 
Locations

Fakultni nemocnice Ostrava

Ostrava, Czech Republic, 708 52

Status
Completed
 
Locations

EKBC, Uj Szent Janos Korhaz es Szakrendelo

Budapest, Hungary, 1125

Status
Completed
 
Locations

UNIFESP/EPM

Sao Paulo, Brazil, 04023-061

Status
Completed
 
Locations

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

Moscow, Russia, 119620

Status
Completed
 
Locations

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

Kaluga, Russia, 248007

Status
Completed
 
Locations

Pediatric Medical University

Saint-Petersburg, Russia, 194100

Status
Completed
 
Locations

City Children Hospital ¿1

Saint-Petersburg, Russia, 198205

Status
Completed
 
Locations

Narodny ustav detskych chorob

Bratislava, Slovakia, 833 41

Status
Completed
 
Locations

MI"Odesa Regional Children's Clinical Hospital"

Odesa, Ukraine, 65031

Status
Completed
 
Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, China, 80756

Status
Completed
 
Locations

Mackay Memorial Hospital

Taipei, Taiwan, China, 10449

Status
Completed
 
Locations

Ginekologiczno-Polozniczy SK UM im. K. Marcinkowskiego

Poznan, Poland, 60-535

Status
Completed
 
Locations

Hospital Público Descentralizado "Dr. Guillermo Rawson"

San Juan, Argentina, 5400

Status
Completed
 
Locations

Russian National Scientific Medical University

Moscow, Russia, 117997

Status
Completed
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden

Status
Completed
 
Locations

P & A KYRIAKOU Children's Hospital

Athens, Greece, 11527

Status
Completed
 
Locations

University General Hospital of Ioannina

Ioannina, Greece, 45500

Status
Completed
 
Locations

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, Greece, 56403

Status
Completed
 
Locations

Birmingham Womens Hospital

Birmingham, United Kingdom, B15 2TG

Status
Completed
 
Locations

Fukushima Medical University Hospital

Fukushima, Japan, 960-1295

Status
Completed
 
Locations

Saitama Children's Medical Center

Saitama, Japan, 330-8777

Status
Completed
 
Locations

Tokyo Metropolitan Bokutoh Hospital

Sumida-ku, Japan, 130-8575

Status
Completed
 
Locations

Tokyo Metropolitan Ohtsuka Hospital

Toshima-ku, Japan, 170-8476

Status
Completed
 
Locations

Tokyo Metropolitan Children's Medical Center

Fuchu, Japan, 183-8561

Status
Completed
 
Locations

Fukuoka University Hospital

Fukuoka, Japan, 814-0180

Status
Completed
 
Locations

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Status
Completed
 
Locations

Kurume University Hospital

Kurume, Japan, 830-0011

Status
Completed
 
Locations

University of Occupational and Environmental Health

Kitakyushu, Japan, 807-8556

Status
Completed
 
Locations

Okinawa Prefectural Nanbu Medical Center and Children's MC

Shimajiri-gun, Japan, 901-1193

Status
Completed
 
Locations

Showa University Hospital

Shinagawa, Japan, 142-8666

Status
Completed
 
Locations

Maxima Medisch Centrum, locatie Veldhoven

VELDHOVEN, Netherlands, 5504 DB

Status
Completed
 
Locations

Hospital das Clínicas de Botucatu - UNESP Botucatu

Botucatu, Brazil, 18618 970

Status
Completed
 
Locations

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia, 50586

Status
Completed
 
Locations

Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda"

Iasi, Romania, 700038

Status
Completed
 
Locations

Clinical Emergency County Hospital

Cluj-Napoca, Romania, 400006

Status
Completed
 
Locations

KK Women's and Children's Hospital

Singapore, Singapore, 229899

Status
Completed
 
Locations

Many Locations

Many Locations, Argentina

Status
Completed
 
Locations

Many Locations

Many Locations, Austria

Status
Completed
 
Locations

Many Locations

Many Locations, Belgium

Status
Completed
 
Locations

Many Locations

Many Locations, Bulgaria

Status
Completed
 
Locations

Many Locations

Many Locations, Brazil

Status
Completed
 
Locations

Many Locations

Many Locations, Czech Republic

Status
Completed
 
Locations

Many Locations

Many Locations, Spain

Status
Completed
 
Locations

Many Locations

Many Locations, United Kingdom

Status
Completed
 
Locations

Many Locations

Many Locations, Greece

Status
Completed
 
Locations

Many Locations

Many Locations, Hong Kong, China

Status
Completed
 
Locations

Many Locations

Many Locations, Hungary

Status
Completed
 
Locations

Many Locations

Many Locations, Israel

Status
Completed
 
Locations

Many Locations

Many Locations, Italy

Status
Completed
 
Locations

Many Locations

Many Locations, Japan

Status
Completed
 
Locations

Many Locations

Many Locations, South Korea

Status
Completed
 
Locations

Many Locations

Many Locations, Malaysia

Status
Completed
 
Locations

Many Locations

Many Locations, Netherlands

Status
Completed
 
Locations

Many Locations

Many Locations, Poland

Status
Completed
 
Locations

Many Locations

Many Locations, Portugal

Status
Completed
 
Locations

Many Locations

Many Locations, Romania

Status
Completed
 
Locations

Many Locations

Many Locations, Russia

Status
Completed
 
Locations

Many Locations

Many Locations, Sweden

Status
Completed
 
Locations

Many Locations

Many Locations, Singapore

Status
Completed
 
Locations

Many Locations

Many Locations, Slovakia

Status
Completed
 
Locations

Many Locations

Many Locations, Turkey

Status
Completed
 
Locations

Many Locations

Many Locations, Taiwan, China

Status
Completed
 
Locations

Many Locations

Many Locations, Ukraine

Status
Completed
 

Trial Design