Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090
NCT ID: NCT04015180
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2020-03-18
2025-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Aflibercept arm
No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.
Eylea (Aflibercept, BAY86-5321)
Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection.
Laser photocoagulation arm
No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.
Laser photocoagulation
Treatment administered in 20090. Transpupillary conventional laser ablative therapy
Interventions
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Eylea (Aflibercept, BAY86-5321)
Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection.
Laser photocoagulation
Treatment administered in 20090. Transpupillary conventional laser ablative therapy
Eligibility Criteria
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Inclusion Criteria
* 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
13 Months
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Locations
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Hospital Público Descentralizado "Dr. Guillermo Rawson"
San Juan, , Argentina
AZ Sint Jan Brugge - Ophthalmology
Bruges, , Belgium
Hospital das Clínicas de Botucatu - UNESP Botucatu
Botucatu, São Paulo, Brazil
Unifesp/Epm
São Paulo, , Brazil
UMHAT Sveti Georgi
Plovdiv, , Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatm
Sofia, , Bulgaria
Spec. Hospital of Ophthalm. for Active Treatment Visus
Sofia, , Bulgaria
Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna
Varna, , Bulgaria
Fakultní nemocnice Ostrava
Ostrava, , Czechia
Všeobecná fakultní nemocnice v Praze
Prague, , Czechia
Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department
Athens, , Greece
General Hospital Of Thessaloniki Papageorgiou-2nd Ophthalmology Clinic
Efkarpia, , Greece
University General Hospital of Ioannina
Ioannina, , Greece
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz és Szakrendelo
Budapest, , Hungary
Kaplan Medical Center
Rehovot, , Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oculistica
Rome, Lazio, Italy
Ospedale Pediatrico Bambino Gesù - Oculistica
Rome, Lazio, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Oculistica
Milan, Lombardy, Italy
A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Oculistica
Perugia, Umbria, Italy
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu, Fukuoka, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Okinawa Prefectural Nanbu Medical Center and Children's MC
Shimajiri-gun, Okinawa, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku, Tokyo, Japan
Tokyo Metropolitan Ohtsuka Hospital
Toshima-ku, Tokyo, Japan
Kyushu University Hospital
Fukuoka, , Japan
Fukuoka University Hospital
Fukuoka, , Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
Maxima Medisch Centrum, locatie Veldhoven
Veldhoven, , Netherlands
Hospital Prof. Dr. Fernando Fonseca
Amadora, Lisbon District, Portugal
Unidade Local De Saúde De Lisboa Ocidental E.P.E.
Lisbon, , Portugal
Clinical Emergency County Hospital
Cluj-Napoca, Cluj, Romania
Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda"
Iași, , Romania
FSAI NMRC IRTC "Eye Microsurgery", Kaluga's Branch
Kaluga, , Russia
FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo"
Moscow, , Russia
City Children Hospital ?1
Saint Petersburg, , Russia
KK Women's and Children's Hospital
Singapore, , Singapore
Narodny ustav detskych chorob
Bratislava, , Slovakia
Soon Chun Hyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, South Korea
Asan Medical Center - Oncology Department
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital la Paz - oftalmologia
Madrid, , Spain
Hospital Universitario Regional De Malaga - Oftalmologia
Málaga, , Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung, Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Hacettepe Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
Gazi Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
Saglik Bilimleri Universitesi Antalya EA Hastanesi
Antalya, , Turkey (Türkiye)
Eskisehir Osmangazi Universitesi Tip Fakultesi
Eskişehir, , Turkey (Türkiye)
Adana Sehir Egitim ve Arastirma Hastanesi
Yüreğir, , Turkey (Türkiye)
Institute of Eye Diseases and Tissue Therapy named after V.I. Filatov, Consultative Polyclinic
Odesa, , Ukraine
Birmingham Womens Hospital
Birmingham, , United Kingdom
Countries
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References
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Stahl 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.
Other Identifiers
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2023-504207-89-00
Identifier Type: OTHER
Identifier Source: secondary_id
2018-003180-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20275
Identifier Type: -
Identifier Source: org_study_id
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