do_not_disturb_altRecruitment Complete
Retinopathy of prematurity (ROP)
Bayer Identifier:
20275
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
2023-504207-89-00
Extension study to evaluate the long-term outcomes of subjects in Study 20090
Trial purpose
This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.
Key Participants Requirements
Sex
AllAge
NaN - 13 MonthsTrial summary
Enrollment Goal
100Trial Dates
March 2020 - October 2025Phase
Phase 3Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hacettepe Universitesi Tip Fakultesi | Ankara, 6100, Turkey |
Withdrawn | Baskent Universitesi Tip Fakultesi Hastanesi | Ankara, 06490, Turkey |
Completed | Eskisehir Osmangazi Universitesi Tip Fakultesi | Eskisehir, 26480, Turkey |
Active, not recruiting | Saglik Bilimleri Universitesi Antalya EA Hastanesi | Antalya, 7100, Turkey |
Withdrawn | A.O.U.I. Verona | Verona, 37126, Italy |
Active, not recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oculistica | Roma, 00136, Italy |
Active, not recruiting | Ospedale Pediatrico Bambino Gesù - Oculistica | Roma, 00165, Italy |
Completed | A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Oculistica | Perugia, 06129, Italy |
Active, not recruiting | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Oculistica | Milano, 20122, Italy |
Completed | Adana Sehir Egitim ve Arastirma Hastanesi | Yüregir, 1370, Turkey |
Completed | Gazi Universitesi Tip Fakultesi | Ankara, 6560, Turkey |
Withdrawn | Medizinische Universität Graz | Graz, 8036, Austria |
Withdrawn | Samsung Medical Center | Seoul, 6351, Korea, Republic Of |
Completed | Asan Medical Center | Seoul, 05505, Korea,_republic_of |
Completed | Soon Chun Hyang University Cheonan Hospital | Cheonan, 31151, Korea,_republic_of |
Withdrawn | Acibadem Saglik Hizmetleri ve Tic. A.S | Istanbul, 34140, Turkey |
Withdrawn | Queen Mary Hospital | Hong Kong, Hong Kong |
Active, not recruiting | Acibadem City Clinic Multiprofile Hospital for Active Treatm | Sofia, 1407, Bulgaria |
Active, not recruiting | UMHAT Sveti Georgi | Plovdiv, 4002, Bulgaria |
Active, not recruiting | Spec. Hospital of Ophthalm. for Active Treatment Visus | Sofia, 1619, Bulgaria |
Active, not recruiting | Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna | Varna, 9000, Bulgaria |
Withdrawn | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Withdrawn | Kepler Universitätsklinikum Campus III | Linz, 4020, Austria |
Withdrawn | Klinikum Klagenfurt am Wörthersee | Klagenfurt, 9020, Austria |
Withdrawn | Inselspital Universitätsspital Bern | Bern, 3010, Switzerland |
Withdrawn | Luzerner Kantonsspital | Luzern, 6000, Switzerland |
Withdrawn | Universitätsklinikum Greifswald | Greifswald, 17475, Germany |
Withdrawn | St. Franziskus-Hospital GmbH | Münster, 48145, Germany |
Withdrawn | Universitätsklinikum Köln | Köln, 50924, Germany |
Withdrawn | Eberhard-Karls-Universität Tübingen | Tübingen, 72076, Germany |
Withdrawn | Universitätsklinikum Carl Gustav Carus Dresden | Dresden, 01307, Germany |
Withdrawn | Medizinische Einrichtungen der Universität Bonn | Bonn, 53105, Germany |
Withdrawn | University of Manchester | Manchester, M13 9PT, United Kingdom |
Withdrawn | Hospital de Sant Joan de Déu | Esplugues de LLobregat, 08950, Spain |
Active, not recruiting | Hospital la Paz - oftalmologia | Madrid, 28046, Spain |
Completed | Hospital Regional de Malaga | Oftalmologia | Málaga, 29011, Spain |
Active, not recruiting | Hospital Universitario 12 de Octubre | Madrid, 28041, Spain |
Withdrawn | Hospital Universitari Son Espases | Palma de Mallorca, 07120, Spain |
Withdrawn | Hospital for Sick Children | Toronto, M5G 1X8, Canada |
Withdrawn | IWK Health Centre | Halifax, B3K 6R8, Canada |
Completed | Maxima Medisch Centrum, locatie Veldhoven | VELDHOVEN, 5504 DB, Netherlands |
Active, not recruiting | Sahlgrenska Universitetssjukhuset | Göteborg, 413 45, Sweden |
Withdrawn | Lunds Universitetssjukhus | Lund, 221 85, Sweden |
Withdrawn | S:t Eriks Ögonsjukhus | Stockholm, 112 82, Sweden |
Active, not recruiting | Všeobecná fakultní nemocnice v Praze | Praha 2, 12808, Czech Republic |
Active, not recruiting | Fakultní nemocnice Ostrava | Ostrava, 708 52, Czech Republic |
Active, not recruiting | UNIFESP/EPM | São Paulo, TBC, Brazil |
Withdrawn | Hospital Municipal Vila Santa Catarina | São Paulo, 04377-038, Brazil |
Active, not recruiting | Hospital das Clínicas de Botucatu - UNESP Botucatu | Botucatu, TBC, Brazil |
Completed | Narodny ustav detskych chorob | Bratislava, 833 41, Slovakia |
Active, not recruiting | Institute of Eye Diseases and Tissue Therapy named after V.I. Filatov, Consultative Polyclinic | Odesa, 65061, Ukraine |
Withdrawn | National Pediatric Specialized Hospital "Okhmatdyt" | Kyiv, 1135, Ukraine |
Completed | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City, 807377, Taiwan |
Withdrawn | Chang Gung Memorial Hospital at Linkou | Taoyuan, 33305, Taiwan |
Completed | Mackay Memorial Hospital | Taipei, 104, Taiwan |
Withdrawn | Karolinska Universitetssjukhuset Huddinge Stockholm | Stockholm, S-141 86, Sweden |
Active, not recruiting | Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department | Athens, MISSING, Greece |
Completed | University General Hospital of Ioannina | Ioannina, 45500, Greece |
Active, not recruiting | General Hospital of Thessaloniki Papageorgiou | Thessaloniki, 56403, Greece |
Withdrawn | Hospital de Clinicas de Porto Alegre | Clinical Research Center - Surgery Research Center | Porto Alegre, 90035-903, Brazil |
Withdrawn | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Active, not recruiting | AZ Sint Jan Brugge - Ophthalmology | Brugge, 8000, Belgium |
Withdrawn | Inst. de Mater. y Gineco. Nuestra Señora de las Mercedes | San MIguel de Tucumán, TBC, Argentina |
Active, not recruiting | Hospital Prof. Dr. Fernando Fonseca | Amadora, 2720-276, Portugal |
Withdrawn | Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica | Loures, 2674-514, Portugal |
Active, not recruiting | Centro Hospitalar de Lisboa Ocidental | Clinical Research Department | Lisboa, 1449-005, Portugal |
Withdrawn | Centro Hospitalar Universitario do Porto | Porto, 4099-001, Portugal |
Withdrawn | ULSM - Hospital Pedro Hispano | Matosinhos, 4464-513, Portugal |
Active, not recruiting | KK Women's and Children's Hospital | Singapore, 229899, Singapore |
Completed | Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz és Szakrendelo | Budapest, H-1125, Hungary |
Withdrawn | Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary |
Withdrawn | Hospital de Niños Sor María Ludovica | La Plata, 1900, Argentina |
Active, not recruiting | Hospital Público Descentralizado "Dr. Guillermo Rawson" | San Juan, 5400, Argentina |
Withdrawn | Sanatorio Argentino | San Juan, J5400ANI, Argentina |
Completed | Hospital Kuala Lumpur | Kuala Lumpur, 50586, Malaysia |
Withdrawn | University Hospital Kebangsaan Malaysia | Cheras, 56000, Malaysia |
Withdrawn | Sapporo City General Hospital | Sapporo, 060-8604, Japan |
Completed | Fukushima Medical University Hospital | Fukushima, 960-1295, Japan |
Withdrawn | Saitama Children's Medical Center | Saitama, 330-8777, Japan |
Active, not recruiting | Tokyo Metropolitan Bokutoh Hospital | Sumida-ku, 130-8575, Japan |
Active, not recruiting | Tokyo Metropolitan Ohtsuka Hospital | Toshima-ku, 170-8476, Japan |
Withdrawn | Tokyo Women's Medical University Yachiyo Medical Center | Yachiyo, 276-8524, Japan |
Withdrawn | National Center for Child Health and Development | Setagaya, 157-8535, Japan |
Withdrawn | Toho University Omori Medical Center | Ota-ku, 143-8541, Japan |
Completed | Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center | Fuchu, 183-8561, Japan |
Withdrawn | Yokohama City University Medical Center | Yokohama, 232-0024, Japan |
Withdrawn | Hamamatsu University Hospital | Hamamatsu, 431-3192, Japan |
Withdrawn | Nagoya University Hospital | Nagoya, 466-8560, Japan |
Withdrawn | Shiga University of Medical Science Hospital | Otsu, 520-2192, Japan |
Active, not recruiting | Kindai University Hospital | Osakasayama-shi, 589-8511, Japan |
Completed | Fukuoka University Hospital | Fukuoka, 814-0180, Japan |
Active, not recruiting | Kyushu University Hospital | Fukuoka, 812-8582, Japan |
Completed | Kurume University Hospital | Kurume, 830-0011, Japan |
Completed | Hospital of the University of Occupational and Environmental Health, Japan | Kitakyushu, 807-8556, Japan |
Completed | Okinawa Prefectural Nanbu Medical Center and Children's MC | Shimajiri-gun, 901-1193, Japan |
Withdrawn | Showa University East Hospital | Shinagawa-ku, 142-0054, Japan |
Withdrawn | Fujita Health University Hospital | Toyoake, 470-1192, Japan |
Withdrawn | Hiroshima City Hiroshima Citizens Hospital | Hiroshima, 730-8518, Japan |
Withdrawn | Nara Medical University Hospital | Kashihara, 634-8522, Japan |
Withdrawn | Juntendo University Urayasu Hospital | Urayasu, 279-0021, Japan |
Withdrawn | Showa University Hospital | Shinagawa, 142-8666, Japan |
Active, not recruiting | FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo" | Moscow, 119620, Russia |
Withdrawn | Russian National Scientific Medical University | Moscow, 117997, Russian Federation |
Withdrawn | FBSI IRTC Eye Microsurgery n.a. acad. S.N. Fyodorov | Moscow, 127486, Russian Federation |
Active, not recruiting | FSAI NMRC IRTC "Eye Microsurgery", Kaluga’s Branch | Kaluga, 248007, Russia |
Withdrawn | Pediatric Medical University | Saint-Petersburg, 194100, Russian Federation |
Active, not recruiting | City Children Hospital ?1 | Saint-Petersburg, 198205, Russia |
Withdrawn | Hadassah Hebrew University Hospital Ein Kerem | Jerusalem, 91120, Israel |
Completed | Kaplan Medical Center | Rehovot, 7610001, Israel |
Withdrawn | Tel-Aviv Sourasky Medical Center | Tel Aviv, 6423906, Israel |
Withdrawn | Clalit Health Services Schneider Children's Medical Center | Petach Tikva, 4920235, Israel |
Withdrawn | Instytut Mikroekologii | Poznan, 60-129, Poland |
Withdrawn | Rambam Health Corporation | Haifa, 3109601, Israel |
Withdrawn | Shamir Medical Center (Assaf Harofeh) | Zerifin, 6093000, Israel |
Active, not recruiting | Birmingham Womens Hospital | Birmingham, B15 2TG, United Kingdom |
Withdrawn | Municipal Clinical Emergency Hospital of Timisoara | Timisoara, 300172, Romania |
Completed | Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda" | Iasi, 700038, Romania |
Active, not recruiting | Clinical Emergency County Hospital | Cluj-Napoca, 400347, Romania |
Withdrawn | Hospital Maternal Nuestra Señora del Pilar | Pilar, TBC, Argentina |
Withdrawn | Hospital of LT University of Health Sciences Kaunas Clinics | Kaunas, LT-50161, Lithuania |
Withdrawn | East Tallinn Central Hospital | Tallinn, 10138, Estonia |
Withdrawn | Children's Clinical University Hospital | Riga, LV-1004, Latvia |
Withdrawn | Vivantes Klinikum Neukölln | Berlin, 12351, Germany |
Primary Outcome
- Binocular best-corrected visual acuity in Snellen equivalentdate_rangeTime Frame:At 5 years of age.
- Proportion of subjects with ocular AEs and SAEsAE: adverse event SAE: serious adverse eventdate_rangeTime Frame:Up to 5 years of age.
- Proportion of subjects with systemic AEs and SAEsdate_rangeTime Frame:Up to 5 years of age.
Secondary Outcome
- Proportion of subjects developing unfavorable ocular structural outcomeUnfavorable ocular structural outcome include: retinal detachment, macular dragging, macular fold, retrolental opacitydate_rangeTime Frame:At 1,3 and 5 years of age.
- Proportion of subjects with absence of active ROP and unfavorable structural outcomesdate_rangeTime Frame:At 1 year of age.
- Best-corrected visual acuity in each eyedate_rangeTime Frame:At 3 and 5 years of age.
- Refractive spherical equivalent in each eyedate_rangeTime Frame:At 3 and 5 years of age
- Neurodevelopmental outcomes using BSID-IIIBSID-III: The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is a standard series of tests that will assess the development of children in 3 areas: cognition, language, and motor skills. It is recommended to be assessed at screening, 1 year and 2 years of age. The assessment at 2 years of age is mandatory.date_rangeTime Frame:At 2 years of age
- Neurodevelopmental outcomes using WPPSI-IVWPPSI-IV: The Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition is designed to assess development of older children and is recommended to be performed at 3, 4 and 5 years of age. The assessment at 5 years of age is mandatory. In cases where the WPSSI-IV cannot be used, the Differential Ability Scales II (DAS-II) may be used as an alternative.date_rangeTime Frame:At 5 years of age
- Neurodevelopmental outcomes using VABS-IIVABS-II: Vineland Adaptive Behavior Scales, Second Edition Expanded Interview will be included, which includes 4 areas: Communication, Daily Living skills, Socialization and Motor Skills. It is recommended to be assessed at 2, 3, 4 and 5 years of age. The assessments at 2 years and 5 years of age are mandatory.date_rangeTime Frame:At 2 and 5 years of age
- Proportion of subjects with recurrence of ROPdate_rangeTime Frame:At 3 and 5 years of age.
- Proportion of subjects requiring treatment for ROPdate_rangeTime Frame:Up to 5 years of age.
- Proportion of subjects requiring ophthalmological treatmentdate_rangeTime Frame:Up to 5 years of age.
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2