Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090
FIREFLEYE next
An Extension Study to Evaluate the Long-term Outcomes of Subjects Who Received Treatment for Retinopathy of Prematurity in Study 20090
3 other identifiers
interventional
100
24 countries
55
Brief Summary
This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2020
Longer than P75 for phase_3
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2019
CompletedFirst Posted
Study publicly available on registry
July 10, 2019
CompletedStudy Start
First participant enrolled
March 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2025
CompletedOctober 10, 2025
October 1, 2025
5.5 years
June 28, 2019
October 9, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Binocular best-corrected visual acuity in Snellen equivalent
At 5 years of age.
Proportion of subjects with ocular AEs and SAEs
AE: adverse event SAE: serious adverse event
Up to 5 years of age.
Proportion of subjects with systemic AEs and SAEs
Up to 5 years of age.
Secondary Outcomes (10)
Proportion of subjects developing unfavorable ocular structural outcome
At 1,3 and 5 years of age.
Proportion of subjects with absence of active ROP and unfavorable structural outcomes
At 1 year of age.
Best-corrected visual acuity in each eye
At 3 and 5 years of age.
Refractive spherical equivalent in each eye
At 3 and 5 years of age
Neurodevelopmental outcomes using BSID-III
At 2 years of age
- +5 more secondary outcomes
Study Arms (2)
Aflibercept arm
EXPERIMENTALNo study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.
Laser photocoagulation arm
ACTIVE COMPARATORNo study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.
Interventions
Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection.
Treatment administered in 20090. Transpupillary conventional laser ablative therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Subject has a condition preventing participation in the study, or performance of study procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Regeneron Pharmaceuticalscollaborator
Study Sites (55)
Hospital Público Descentralizado "Dr. Guillermo Rawson"
San Juan, 5400, Argentina
AZ Sint Jan Brugge - Ophthalmology
Bruges, 8000, Belgium
Hospital das Clínicas de Botucatu - UNESP Botucatu
Botucatu, São Paulo, TBC, Brazil
Unifesp/Epm
São Paulo, 04024-002, Brazil
UMHAT Sveti Georgi
Plovdiv, 4002, Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatm
Sofia, 1407, Bulgaria
Spec. Hospital of Ophthalm. for Active Treatment Visus
Sofia, 1619, Bulgaria
Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna
Varna, 9000, Bulgaria
Fakultní nemocnice Ostrava
Ostrava, 708 52, Czechia
Všeobecná fakultní nemocnice v Praze
Prague, 12808, Czechia
Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department
Athens, MISSING, Greece
General Hospital Of Thessaloniki Papageorgiou-2nd Ophthalmology Clinic
Efkarpia, 564 29, Greece
University General Hospital of Ioannina
Ioannina, 45500, Greece
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz és Szakrendelo
Budapest, H-1125, Hungary
Kaplan Medical Center
Rehovot, 7610001, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oculistica
Rome, Lazio, 00136, Italy
Ospedale Pediatrico Bambino Gesù - Oculistica
Rome, Lazio, 00165, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Oculistica
Milan, Lombardy, 20122, Italy
A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Oculistica
Perugia, Umbria, 06129, Italy
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu, Fukuoka, 807-8556, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
Okinawa Prefectural Nanbu Medical Center and Children's MC
Shimajiri-gun, Okinawa, 901-1193, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511, Japan
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, 183-8561, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku, Tokyo, 130-8575, Japan
Tokyo Metropolitan Ohtsuka Hospital
Toshima-ku, Tokyo, 170-8476, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
Maxima Medisch Centrum, locatie Veldhoven
Veldhoven, 5504 DB, Netherlands
Hospital Prof. Dr. Fernando Fonseca
Amadora, Lisbon District, 2720-276, Portugal
Unidade Local De Saúde De Lisboa Ocidental E.P.E.
Lisbon, 1449-005, Portugal
Clinical Emergency County Hospital
Cluj-Napoca, Cluj, 400347, Romania
Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda"
Iași, 700038, Romania
FSAI NMRC IRTC "Eye Microsurgery", Kaluga's Branch
Kaluga, 248007, Russia
FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo"
Moscow, 119620, Russia
City Children Hospital ?1
Saint Petersburg, 198205, Russia
KK Women's and Children's Hospital
Singapore, 229899, Singapore
Narodny ustav detskych chorob
Bratislava, 833 41, Slovakia
Soon Chun Hyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, 31151, South Korea
Asan Medical Center - Oncology Department
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital la Paz - oftalmologia
Madrid, 28046, Spain
Hospital Universitario Regional De Malaga - Oftalmologia
Málaga, 29011, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung, 807377, Taiwan
Mackay Memorial Hospital
Taipei, 104, Taiwan
Hacettepe Universitesi Tip Fakultesi
Ankara, 6100, Turkey (Türkiye)
Gazi Universitesi Tip Fakultesi
Ankara, 6560, Turkey (Türkiye)
Saglik Bilimleri Universitesi Antalya EA Hastanesi
Antalya, 7100, Turkey (Türkiye)
Eskisehir Osmangazi Universitesi Tip Fakultesi
Eskişehir, 26480, Turkey (Türkiye)
Adana Sehir Egitim ve Arastirma Hastanesi
Yüreğir, 1370, Turkey (Türkiye)
Institute of Eye Diseases and Tissue Therapy named after V.I. Filatov, Consultative Polyclinic
Odesa, 65061, Ukraine
Birmingham Womens Hospital
Birmingham, B15 2TG, United Kingdom
Related Publications (2)
Stahl A, Nakanishi H, Lepore D, Wu WC, Azuma N, Jacas C, Athanikar A, Vitti R, Chu K, Iveli P, Zhao F, Schlief S, Leal S, Niesen T, Brandau K, Miller T, Kofuncu E, Fielder AR. Three-year Outcomes of Intravitreal Aflibercept versus Laser Therapy for Retinopathy of Prematurity. Neonatology. 2026 Jan 8:1-19. doi: 10.1159/000549717. Online ahead of print.
PMID: 41505377DERIVEDStahl A, Nakanishi H, Lepore D, Wu WC, Azuma N, Jacas C, Vitti R, Athanikar A, Chu K, Iveli P, Zhao F, Leal S, Schlief S, Schmelter T, Miller T, Kofuncu E, Fielder A; FIREFLEYE next Study Group. Intravitreal Aflibercept vs Laser Therapy for Retinopathy of Prematurity: Two-Year Efficacy and Safety Outcomes in the Nonrandomized Controlled Trial FIREFLEYE next. JAMA Netw Open. 2024 Apr 1;7(4):e248383. doi: 10.1001/jamanetworkopen.2024.8383.
PMID: 38687481DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2019
First Posted
July 10, 2019
Study Start
March 18, 2020
Primary Completion
September 19, 2025
Study Completion
September 19, 2025
Last Updated
October 10, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.