Clinical trial NCT04015180: Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090
Official title: An Extension Study to Evaluate the Long-term Outcomes of Subjects Who Received Treatment for Retinopathy of Prematurity in Study 20090
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Retinopathy of Prematurity (ROP)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2019-07-10
Enrollment: 100
Sex: ALL
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.


Eligibility criteria: 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.

Primary outcomes:
measure: Binocular best-corrected visual acuity in Snellen equivalent
timeFrame: At 5 years of age.
measure: Proportion of subjects with ocular AEs and SAEs
timeFrame: Up to 5 years of age.
measure: Proportion of subjects with systemic AEs and SAEs
timeFrame: Up to 5 years of age.
Secondary outcomes:
measure: Proportion of subjects developing unfavorable ocular structural outcome
timeFrame: At 1,3 and 5 years of age.
measure: Proportion of subjects with absence of active ROP and unfavorable structural outcomes
timeFrame: At 1 year of age.
measure: Best-corrected visual acuity in each eye
timeFrame: At 3 and 5 years of age.
measure: Refractive spherical equivalent in each eye
timeFrame: At 3 and 5 years of age
measure: Neurodevelopmental outcomes using BSID-III
timeFrame: At 2 years of age
measure: Neurodevelopmental outcomes using WPPSI-IV
timeFrame: At 5 years of age
measure: Neurodevelopmental outcomes using VABS-II
timeFrame: At 2 and 5 years of age
measure: Proportion of subjects with recurrence of ROP
timeFrame: At 3 and 5 years of age.
measure: Proportion of subjects requiring treatment for ROP
timeFrame: Up to 5 years of age.
measure: Proportion of subjects requiring ophthalmological treatment
timeFrame: Up to 5 years of age.
Other outcomes:
Locations:
city: San Juan
country: Argentina
facility: Hospital Público Descentralizado "Dr. Guillermo Rawson"
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge - Ophthalmology
city: Botucatu
country: Brazil
facility: Hospital das Clínicas de Botucatu - UNESP Botucatu
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Unifesp/Epm
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Multiprofile Hospital for Active Treatm
city: Sofia
country: Bulgaria
facility: Spec. Hospital of Ophthalm. for Active Treatment Visus
city: Varna
country: Bulgaria
facility: Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna
city: Ostrava
country: Czechia
facility: Fakultní nemocnice Ostrava
city: Praha 2
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
city: Athens
country: Greece
facility: Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Papageorgiou
city: Budapest
country: Hungary
facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz és Szakrendelo
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oculistica
state: Lazio
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù - Oculistica
state: Lazio
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Oculistica
state: Lombardia
city: Perugia
country: Italy
facility: A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Oculistica
state: Umbria
city: Kitakyushu
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Shimajiri-gun
country: Japan
facility: Okinawa Prefectural Nanbu Medical Center and Children's MC
state: Okinawa
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Fuchu
country: Japan
facility: Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center
state: Tokyo
city: Sumida-ku
country: Japan
facility: Tokyo Metropolitan Bokutoh Hospital
state: Tokyo
city: Toshima-ku
country: Japan
facility: Tokyo Metropolitan Ohtsuka Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Cheonan Hospital
state: Chungcheongnamdo
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul Teugbyeolsi
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum, locatie Veldhoven
city: Amadora
country: Portugal
facility: Hospital Prof. Dr. Fernando Fonseca
state: Lisboa
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental | Clinical Research Department
city: Cluj-Napoca
country: Romania
facility: Clinical Emergency County Hospital
state: Cluj
city: Iasi
country: Romania
facility: Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda"
city: Kaluga
country: Russian Federation
facility: FSAI NMRC IRTC "Eye Microsurgery", Kaluga's Branch
city: Moscow
country: Russian Federation
facility: FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo"
city: Saint-Petersburg
country: Russian Federation
facility: City Children Hospital ?1
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Bratislava
country: Slovakia
facility: Narodny ustav detskych chorob
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital la Paz - oftalmologia
city: Málaga
country: Spain
facility: Hospital Universitario Regional De Malaga - Oftalmologia
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
state: Kaohsiung
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi
city: Antalya
country: Turkey
facility: Saglik Bilimleri Universitesi Antalya EA Hastanesi
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi Universitesi Tip Fakultesi
city: Yuregir
country: Turkey
facility: Adana Sehir Egitim ve Arastirma Hastanesi
city: Odesa
country: Ukraine
facility: Institute of Eye Diseases and Tissue Therapy named after V.I. Filatov, Consultative Polyclinic
city: Birmingham
country: United Kingdom
facility: Birmingham Womens Hospital
Study officials:
References: