do_not_disturb_altRecruitment Complete

Retinopathy of prematurity (ROP)

Bayer Identifier:

20275

ClinicalTrials.gov Identifier:

NCT04015180

EudraCT Number:

2018-003180-54

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

All

Age

NaN - 13 Months
  • - 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
  • - Subject has a condition preventing participation in the study, or performance of study procedures.

Trial summary

Enrollment Goal
100
Trial Dates
March 2020 - October 2025
Phase
Phase 3
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hacettepe Universitesi Tip FakultesiAnkara, 6100, Turkey
Withdrawn
Baskent Universitesi Tip Fakultesi HastanesiAnkara, 06490, Turkey
Completed
Eskisehir Osmangazi Universitesi Tip FakultesiEskisehir, 26480, Turkey
Active, not recruiting
Saglik Bilimleri Universitesi Antalya EA HastanesiAntalya, 7100, Turkey
Withdrawn
A.O.U.I. VeronaVerona, 37126, Italy
Completed
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC OculisticaRoma, 00136, Italy
Completed
Ospedale Pediatrico Bambino Gesù - OculisticaRoma, 00165, Italy
Completed
A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. OculisticaPerugia, 06129, Italy
Active, not recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - OculisticaMilano, 20122, Italy
Completed
Adana Sehir Egitim ve Arastirma HastanesiYüregir, 1370, Turkey
Completed
Gazi Universitesi Tip FakultesiAnkara, 6560, Turkey
Withdrawn
Medizinische Universität GrazGraz, 8036, Austria
Withdrawn
Samsung Medical CenterSeoul, 6351, Korea, Republic Of
Completed
Asan Medical CenterSeoul, 05505, Korea,_republic_of
Completed
Soon Chun Hyang University Cheonan HospitalCheonan, 31151, Korea,_republic_of
Withdrawn
Acibadem Saglik Hizmetleri ve Tic. A.SIstanbul, 34140, Turkey
Withdrawn
Queen Mary HospitalHong Kong, Hong Kong
Active, not recruiting
Acibadem City Clinic Multiprofile Hospital for Active TreatmSofia, 1407, Bulgaria
Active, not recruiting
UMHAT Sveti GeorgiPlovdiv, 4002, Bulgaria
Active, not recruiting
Spec. Hospital of Ophthalm. for Active Treatment VisusSofia, 1619, Bulgaria
Active, not recruiting
Spec. Hosp. of Ophthalm. Disease for Active Treatment VarnaVarna, 9000, Bulgaria
Withdrawn
Universitätsklinikum AKH WienWien, 1090, Austria
Withdrawn
Kepler Universitätsklinikum Campus IIILinz, 4020, Austria
Withdrawn
Klinikum Klagenfurt am WörtherseeKlagenfurt, 9020, Austria
Withdrawn
Inselspital Universitätsspital BernBern, 3010, Switzerland
Withdrawn
Luzerner KantonsspitalLuzern, 6000, Switzerland
Withdrawn
Universitätsklinikum GreifswaldGreifswald, 17475, Germany
Withdrawn
St. Franziskus-Hospital GmbHMünster, 48145, Germany
Withdrawn
Universitätsklinikum KölnKöln, 50924, Germany
Withdrawn
Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Withdrawn
Universitätsklinikum Carl Gustav Carus DresdenDresden, 01307, Germany
Withdrawn
Medizinische Einrichtungen der Universität BonnBonn, 53105, Germany
Withdrawn
University of ManchesterManchester, M13 9PT, United Kingdom
Withdrawn
Hospital de Sant Joan de DéuEsplugues de LLobregat, 08950, Spain
Active, not recruiting
Hospital la Paz - oftalmologiaMadrid, 28046, Spain
Completed
Hospital Regional de Malaga | OftalmologiaMálaga, 29011, Spain
Active, not recruiting
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Withdrawn
Hospital Universitari Son EspasesPalma de Mallorca, 07120, Spain
Withdrawn
Hospital for Sick ChildrenToronto, M5G 1X8, Canada
Withdrawn
IWK Health CentreHalifax, B3K 6R8, Canada
Completed
Maxima Medisch Centrum, locatie VeldhovenVELDHOVEN, 5504 DB, Netherlands
Active, not recruiting
Sahlgrenska UniversitetssjukhusetGöteborg, 413 45, Sweden
Withdrawn
Lunds UniversitetssjukhusLund, 221 85, Sweden
Withdrawn
S:t Eriks ÖgonsjukhusStockholm, 112 82, Sweden
Active, not recruiting
Všeobecná fakultní nemocnice v PrazePraha 2, 12808, Czech Republic
Active, not recruiting
Fakultní nemocnice OstravaOstrava, 708 52, Czech Republic
Active, not recruiting
UNIFESP/EPMSão Paulo, TBC, Brazil
Withdrawn
Hospital Municipal Vila Santa CatarinaSão Paulo, 04377-038, Brazil
Active, not recruiting
Hospital das Clínicas de Botucatu - UNESP BotucatuBotucatu, TBC, Brazil
Completed
Narodny ustav detskych chorobBratislava, 833 41, Slovakia
Active, not recruiting
Institute of Eye Diseases and Tissue Therapy named after V.I. Filatov, Consultative PolyclinicOdesa, 65061, Ukraine
Withdrawn
National Pediatric Specialized Hospital "Okhmatdyt"Kyiv, 1135, Ukraine
Completed
Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, 807377, Taiwan
Withdrawn
Chang Gung Memorial Hospital at LinkouTaoyuan, 33305, Taiwan
Completed
Mackay Memorial HospitalTaipei, 104, Taiwan
Withdrawn
Karolinska Universitetssjukhuset Huddinge StockholmStockholm, S-141 86, Sweden
Active, not recruiting
Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology DepartmentAthens, MISSING, Greece
Completed
University General Hospital of IoanninaIoannina, 45500, Greece
Active, not recruiting
General Hospital of Thessaloniki PapageorgiouThessaloniki, 56403, Greece
Withdrawn
Hospital de Clinicas de Porto Alegre | Clinical Research Center - Surgery Research CenterPorto Alegre, 90035-903, Brazil
Withdrawn
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
AZ Sint Jan Brugge - OphthalmologyBrugge, 8000, Belgium
Withdrawn
Inst. de Mater. y Gineco. Nuestra Señora de las MercedesSan MIguel de Tucumán, TBC, Argentina
Completed
Hospital Prof. Dr. Fernando FonsecaAmadora, 2720-276, Portugal
Withdrawn
Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao ClinicaLoures, 2674-514, Portugal
Completed
Centro Hospitalar de Lisboa Ocidental | Clinical Research DepartmentLisboa, 1449-005, Portugal
Withdrawn
Centro Hospitalar Universitario do PortoPorto, 4099-001, Portugal
Withdrawn
ULSM - Hospital Pedro HispanoMatosinhos, 4464-513, Portugal
Active, not recruiting
KK Women's and Children's HospitalSingapore, 229899, Singapore
Completed
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz és SzakrendeloBudapest, H-1125, Hungary
Withdrawn
Debreceni Egyetem Klinikai KozpontDebrecen, 4032, Hungary
Withdrawn
Hospital de Niños Sor María LudovicaLa Plata, 1900, Argentina
Active, not recruiting
Hospital Público Descentralizado "Dr. Guillermo Rawson"San Juan, 5400, Argentina
Withdrawn
Sanatorio ArgentinoSan Juan, J5400ANI, Argentina
Completed
Hospital Kuala LumpurKuala Lumpur, 50586, Malaysia
Withdrawn
University Hospital Kebangsaan MalaysiaCheras, 56000, Malaysia
Withdrawn
Sapporo City General HospitalSapporo, 060-8604, Japan
Completed
Fukushima Medical University HospitalFukushima, 960-1295, Japan
Withdrawn
Saitama Children's Medical CenterSaitama, 330-8777, Japan
Active, not recruiting
Tokyo Metropolitan Bokutoh HospitalSumida-ku, 130-8575, Japan
Active, not recruiting
Tokyo Metropolitan Ohtsuka HospitalToshima-ku, 170-8476, Japan
Withdrawn
Tokyo Women's Medical University Yachiyo Medical CenterYachiyo, 276-8524, Japan
Withdrawn
National Center for Child Health and DevelopmentSetagaya, 157-8535, Japan
Withdrawn
Toho University Omori Medical CenterOta-ku, 143-8541, Japan
Completed
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical CenterFuchu, 183-8561, Japan
Withdrawn
Yokohama City University Medical CenterYokohama, 232-0024, Japan
Withdrawn
Hamamatsu University HospitalHamamatsu, 431-3192, Japan
Withdrawn
Nagoya University HospitalNagoya, 466-8560, Japan
Withdrawn
Shiga University of Medical Science HospitalOtsu, 520-2192, Japan
Active, not recruiting
Kindai University HospitalOsakasayama-shi, 589-8511, Japan
Completed
Fukuoka University HospitalFukuoka, 814-0180, Japan
Active, not recruiting
Kyushu University HospitalFukuoka, 812-8582, Japan
Completed
Kurume University HospitalKurume, 830-0011, Japan
Completed
Hospital of the University of Occupational and Environmental Health, JapanKitakyushu, 807-8556, Japan
Completed
Okinawa Prefectural Nanbu Medical Center and Children's MCShimajiri-gun, 901-1193, Japan
Withdrawn
Showa University East HospitalShinagawa-ku, 142-0054, Japan
Withdrawn
Fujita Health University HospitalToyoake, 470-1192, Japan
Withdrawn
Hiroshima City Hiroshima Citizens HospitalHiroshima, 730-8518, Japan
Withdrawn
Nara Medical University HospitalKashihara, 634-8522, Japan
Withdrawn
Juntendo University Urayasu HospitalUrayasu, 279-0021, Japan
Withdrawn
Showa University HospitalShinagawa, 142-8666, Japan
Active, not recruiting
FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo"Moscow, 119620, Russia
Withdrawn
Russian National Scientific Medical UniversityMoscow, 117997, Russian Federation
Withdrawn
FBSI IRTC Eye Microsurgery n.a. acad. S.N. FyodorovMoscow, 127486, Russian Federation
Completed
FSAI NMRC IRTC "Eye Microsurgery", Kaluga’s BranchKaluga, 248007, Russia
Withdrawn
Pediatric Medical UniversitySaint-Petersburg, 194100, Russian Federation
Active, not recruiting
City Children Hospital ?1Saint-Petersburg, 198205, Russia
Withdrawn
Hadassah Hebrew University Hospital Ein KeremJerusalem, 91120, Israel
Completed
Kaplan Medical CenterRehovot, 7610001, Israel
Withdrawn
Tel-Aviv Sourasky Medical CenterTel Aviv, 6423906, Israel
Withdrawn
Clalit Health Services Schneider Children's Medical CenterPetach Tikva, 4920235, Israel
Withdrawn
Instytut MikroekologiiPoznan, 60-129, Poland
Withdrawn
Rambam Health CorporationHaifa, 3109601, Israel
Withdrawn
Shamir Medical Center (Assaf Harofeh)Zerifin, 6093000, Israel
Completed
Birmingham Womens HospitalBirmingham, B15 2TG, United Kingdom
Withdrawn
Municipal Clinical Emergency Hospital of TimisoaraTimisoara, 300172, Romania
Completed
Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda"Iasi, 700038, Romania
Active, not recruiting
Clinical Emergency County HospitalCluj-Napoca, 400347, Romania
Withdrawn
Hospital Maternal Nuestra Señora del PilarPilar, TBC, Argentina
Withdrawn
Hospital of LT University of Health Sciences Kaunas ClinicsKaunas, LT-50161, Lithuania
Withdrawn
East Tallinn Central HospitalTallinn, 10138, Estonia
Withdrawn
Children's Clinical University HospitalRiga, LV-1004, Latvia
Withdrawn
Vivantes Klinikum NeuköllnBerlin, 12351, Germany

Primary Outcome

  • Binocular best-corrected visual acuity in Snellen equivalent
    date_rangeTime Frame:
    At 5 years of age.
  • Proportion of subjects with ocular AEs and SAEs
    AE: adverse event SAE: serious adverse event
    date_rangeTime Frame:
    Up to 5 years of age.
  • Proportion of subjects with systemic AEs and SAEs
    date_rangeTime Frame:
    Up to 5 years of age.

Secondary Outcome

  • Proportion of subjects developing unfavorable ocular structural outcome
    Unfavorable ocular structural outcome include: retinal detachment, macular dragging, macular fold, retrolental opacity
    date_rangeTime Frame:
    At 1,3 and 5 years of age.
  • Proportion of subjects with absence of active ROP and unfavorable structural outcomes
    date_rangeTime Frame:
    At 1 year of age.
  • Best-corrected visual acuity in each eye
    date_rangeTime Frame:
    At 3 and 5 years of age.
  • Refractive spherical equivalent in each eye
    date_rangeTime Frame:
    At 3 and 5 years of age
  • Neurodevelopmental outcomes using BSID-III
    BSID-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-IV
    WPPSI-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-II
    VABS-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 ROP
    date_rangeTime Frame:
    At 3 and 5 years of age.
  • Proportion of subjects requiring treatment for ROP
    date_rangeTime Frame:
    Up to 5 years of age.
  • Proportion of subjects requiring ophthalmological treatment
    date_rangeTime Frame:
    Up to 5 years of age.

Trial design

An extension study to evaluate the long-term outcomes of subjects who received treatment for retinopathy of prematurity in Study 20090
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2