Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090

Retinopathy of Prematurity (ROP) Clinical Trial

— FIREFLEYE next  

Official title:

An Extension Study to Evaluate the Long-term Outcomes of Subjects Who Received Treatment for Retinopathy of Prematurity in Study 20090

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04015180
• Other study ID #: 20275
• Secondary ID: 2023-504207-89-0
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 18, 2020
• Est. completion date: October 1, 2025

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 13 Months

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity
• Retinopathy of Prematurity (ROP)

Intervention

Drug:
• Eylea (Aflibercept, BAY86-5321)
Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection.

Procedure:
• Laser photocoagulation
Treatment administered in 20090. Transpupillary conventional laser ablative therapy

Locations

Country	Name	City	State
Argentina	Hospital Público Descentralizado "Dr. Guillermo Rawson"	San Juan
Belgium	AZ Sint-Jan Brugge-Oostende | Sint-Jan - Cardiology	Brugge
Brazil	Hospital das Clínicas de Botucatu - UNESP Botucatu	Botucatu	Sao Paulo
Brazil	Unifesp/Epm	Sao Paulo
Bulgaria	UMHAT Sveti Georgi	Plovdiv
Bulgaria	Acibadem City Clinic Multiprofile Hospital for Active Treatm	Sofia
Bulgaria	Spec. Hospital of Ophthalm. for Active Treatment Visus	Sofia
Bulgaria	Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna	Varna
Czechia	Fakultni nemocnice Ostrava	Ostrava
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Greece	P & A KYRIAKOU Children's Hospital	Athens
Greece	University General Hospital of Ioannina	Ioannina
Greece	Papageorgiou General Hospital of Thessaloniki	Thessaloniki
Hungary	Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz és Szakrendelo	Budapest
Israel	Kaplan Medical Center	Rehovot
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano	Lombardia
Italy	A.O. di Perugia	Perugia	Umbria
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Lazio
Italy	IRCCS Ospedale Pediatrico Bambino Gesù	Roma	Lazio
Japan	Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center	Fuchu	Tokyo
Japan	Fukuoka University Hospital	Fukuoka
Japan	Kyushu University Hospital	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Hospital of the University of Occupational and Environmental Health, Japan	Kitakyushu	Fukuoka
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Kindai University Hospital	Osakasayama	Osaka
Japan	Okinawa Prefectural Nanbu Medical Center and Children's MC	Shimajiri-gun	Okinawa
Japan	Tokyo Metropolitan Bokutoh Hospital	Sumida-ku	Tokyo
Japan	Tokyo Metropolitan Ohtsuka Hospital	Toshima-ku	Tokyo
Korea, Republic of	Soon Chun Hyang University Cheonan Hospital	Cheonan	Chungcheongnamdo
Korea, Republic of	Asan Medical Center	Seoul
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur
Netherlands	Maxima Medisch Centrum, locatie Veldhoven	Veldhoven
Portugal	Hospital Prof. Dr. Fernando Fonseca	Amadora	Lisboa
Portugal	Centro Hospitalar de Lisboa Ocidental | Clin Res Dept	Lisboa
Romania	Clinical Emergency County Hospital	Cluj-Napoca	Cluj
Romania	Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda"	Iasi
Russian Federation	FSAI NMRC IRTC "Eye Microsurgery", Kaluga's Branch	Kaluga
Russian Federation	FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo"	Moscow
Russian Federation	City Children Hospital ¿1	Saint-Petersburg
Singapore	KK Women's and Children's Hospital	Singapore
Slovakia	Narodny ustav detskych chorob	Bratislava
Spain	Hospital la Paz - oftalmologia	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Regional de Malaga | Oftalmologia	Málaga
Sweden	Sahlgrenska Universitetssjukhuset	Göteborg
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City	Kaohsiung
Taiwan	Mackay Memorial Hospital	Taipei
Turkey	Gazi Universitesi Tip Fakultesi	Ankara
Turkey	Hacettepe Universitesi Tip Fakultesi	Ankara
Turkey	Saglik Bilimleri Universitesi Antalya EA Hastanesi	Antalya
Turkey	Eskisehir Osmangazi Universitesi Tip Fakultesi	Eskisehir
Turkey	Adana Sehir Egitim ve Arastirma Hastanesi	Yüregir
Ukraine	The Filatov Institute of Eye Diseases and Tissue Therapy	Odesa
United Kingdom	Birmingham Womens Hospital	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Belgium,  Brazil,  Bulgaria,  Czechia,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Netherlands,  Portugal,  Romania,  Russian Federation,  Singapore,  Slovakia,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular best-corrected visual acuity in Snellen equivalent		At 5 years of age.
Primary	Proportion of subjects with ocular AEs and SAEs	AE: adverse event SAE: serious adverse event	Up to 5 years of age.
Primary	Proportion of subjects with systemic AEs and SAEs		Up to 5 years of age.
Secondary	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.
Secondary	Proportion of subjects with absence of active ROP and unfavorable structural outcomes		At 1 year of age.
Secondary	Best-corrected visual acuity in each eye		At 3 and 5 years of age.
Secondary	Refractive spherical equivalent in each eye		At 3 and 5 years of age
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of subjects with recurrence of ROP		At 3 and 5 years of age.
Secondary	Proportion of subjects requiring treatment for ROP		Up to 5 years of age.
Secondary	Proportion of subjects requiring ophthalmological treatment		Up to 5 years of age.