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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504207-89-00 | Other Identifier | CTIS (EU) | |
| 2018-003180-54 | EudraCT Number |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept arm | Experimental | No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090. |
|
| Laser photocoagulation arm | Active Comparator | No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eylea (Aflibercept, BAY86-5321) | Drug | Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects developing unfavorable ocular structural outcome | Unfavorable ocular structural outcome include: retinal detachment, macular dragging, macular fold, retrolental opacity | At 1,3 and 5 years of age. |
| Proportion of subjects with absence of active ROP and unfavorable structural outcomes |
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Inclusion Criteria:
Exclusion Criteria:
- Subject has a condition preventing participation in the study, or performance of study procedures.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Público Descentralizado "Dr. Guillermo Rawson" | San Juan | 5400 | Argentina | |||
| AZ Sint Jan Brugge - Ophthalmology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38687481 | Derived | 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. |
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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.
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| Laser photocoagulation | Procedure | Treatment administered in 20090. Transpupillary conventional laser ablative therapy |
|
| 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 | 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. | 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. | 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. | At 2 and 5 years of age |
| Proportion of subjects with recurrence of ROP | At 3 and 5 years of age. |
| Proportion of subjects requiring treatment for ROP | Up to 5 years of age. |
| Proportion of subjects requiring ophthalmological treatment | Up to 5 years of age. |
| 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 |
| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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