Trial Condition(s):
Retinopathy of prematurity (ROP)
Extension study to evaluate the long-term outcomes of subjects in Study 20090 (FIREFLEYE next)
Bayer Identifier:
20275
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
2023-504207-89-00
Trial Purpose
This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.
Inclusion Criteria
- 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
Exclusion Criteria
- Subject has a condition preventing participation in the study, or performance of study procedures.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Hacettepe Universitesi Tip Fakultesi Ankara, Turkey, 6100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eskisehir Osmangazi Universitesi Tip Fakultesi Eskisehir, Turkey, 26480 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saglik Bilimleri Universitesi Antalya EA Hastanesi Antalya, Turkey, 7100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oculistica Roma, Italy, 00136 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale Pediatrico Bambino Gesù - Oculistica Roma, Italy, 00165 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Oculistica Perugia, Italy, 06129 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Oculistica Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Adana Sehir Egitim ve Arastirma Hastanesi Yüregir, Turkey, 1370 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gazi Universitesi Tip Fakultesi Ankara, Turkey, 6560 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asan Medical Center Seoul, Unmapped, 05505 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Soon Chun Hyang University Cheonan Hospital Cheonan, Unmapped, 31151 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Acibadem City Clinic Multiprofile Hospital for Active Treatm Sofia, Bulgaria, 1407 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Sveti Georgi Plovdiv, Bulgaria, 4002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spec. Hospital of Ophthalm. for Active Treatment Visus Sofia, Bulgaria, 1619 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna Varna, Bulgaria, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital la Paz - oftalmologia Madrid, Spain, 28046 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Regional de Malaga | Oftalmologia Málaga, Spain, 29011 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Maxima Medisch Centrum, locatie Veldhoven VELDHOVEN, Netherlands, 5504 DB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sahlgrenska Universitetssjukhuset Göteborg, Sweden, 413 45 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vseobecna fakultni nemocnice v Praze Praha 2, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultní nemocnice Ostrava Ostrava, Czech Republic, 708 52 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UNIFESP/EPM São Paulo, Brazil, TBC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital das Clínicas de Botucatu - UNESP Botucatu Botucatu, Brazil, TBC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Narodny ustav detskych chorob Bratislava, Slovakia, 833 41 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institute of Eye Diseases and Tissue Therapy named after V.I. Filatov, Consultative Polyclinic Odesa, Ukraine, 65061 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, Taiwan, China, 807377 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mackay Memorial Hospital Taipei, Taiwan, China, 104 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Children's Hospital of Athens P&A Kyriakou Athens, Greece, MISSING | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Ioannina Ioannina, Greece, 45500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations General Hospital of Thessaloniki Papageorgiou Thessaloniki, Greece, 56403 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Sint Jan Brugge - Ophthalmology Brugge, Belgium, 8000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Prof. Dr. Fernando Fonseca Amadora, Portugal, 2720-276 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar de Lisboa Ocidental | Clinical Research Department Lisboa, Portugal, 1449-005 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations KK Women's and Children's Hospital Singapore, Singapore, 229899 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz és Szakrendelo Budapest, Hungary, H-1125 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Público Descentralizado "Dr. Guillermo Rawson" San Juan, Argentina, 5400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Kuala Lumpur Kuala Lumpur, Malaysia, 50586 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukushima Medical University Hospital Fukushima, Japan, 960-1295 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokyo Metropolitan Bokutoh Hospital Sumida-ku, Japan, 130-8575 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokyo Metropolitan Ohtsuka Hospital Toshima-ku, Japan, 170-8476 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center Fuchu, Japan, 183-8561 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kindai University Hospital Osakasayama-shi, Japan, 589-8511 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukuoka University Hospital Fukuoka, Japan, 814-0180 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyushu University Hospital Fukuoka, Japan, 812-8582 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kurume University Hospital Kurume, Japan, 830-0011 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital of the University of Occupational and Environmental Health, Japan Kitakyushu, Japan, 807-8556 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Okinawa Prefectural Nanbu Medical Center and Children's MC Shimajiri-gun, Japan, 901-1193 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo" Moscow, Russia, 119620 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations FSAI NMRC IRTC "Eye Microsurgery", Kaluga’s Branch Kaluga, Russia, 248007 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Children Hospital ?1 Saint-Petersburg, Russia, 198205 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kaplan Medical Center Rehovot, Israel, 7610001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Birmingham Womens Hospital Birmingham, United Kingdom, B15 2TG | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda" Iasi, Romania, 700038 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Emergency County Hospital Cluj-Napoca, Romania, 400347 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
Primary Outcome
- Binocular best-corrected visual acuity in Snellen equivalentTimeframe: At 5 years of age.
- Proportion of subjects with ocular AEs and SAEsAE: adverse event SAE: serious adverse eventTimeframe: Up to 5 years of age.
- Proportion of subjects with systemic AEs and SAEsTimeframe: 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 opacityTimeframe: At 1,3 and 5 years of age.
- Proportion of subjects with absence of active ROP and unfavorable structural outcomesTimeframe: At 1 year of age.
- Best-corrected visual acuity in each eyeTimeframe: At 3 and 5 years of age.
- Refractive spherical equivalent in each eyeTimeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: At 2 and 5 years of age
- Proportion of subjects with recurrence of ROPTimeframe: At 3 and 5 years of age.
- Proportion of subjects requiring treatment for ROPTimeframe: Up to 5 years of age.
- Proportion of subjects requiring ophthalmological treatmentTimeframe: Up to 5 years of age.
Additional Information
Not Available
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