Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090 (FIREFLEYE next)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Retinopathy of Prematurity (ROP)
• Intervention / Treatment: Drug: Eylea (Aflibercept, BAY86-5321); Procedure: Laser photocoagulation

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • San Juan, Argentina, 5400
    • Hospital Público Descentralizado "Dr. Guillermo Rawson"
• Belgium
  • Brugge, Belgium, 8000
    • AZ Sint-Jan Brugge-Oostende | Sint-Jan - Cardiology
• Brazil
  • Sao Paulo, Brazil, 04023-061
    • Unifesp/Epm
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil, 18618 970
      • Hospital das Clínicas de Botucatu - UNESP Botucatu
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • UMHAT Sveti Georgi
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Multiprofile Hospital for Active Treatm
  • Sofia, Bulgaria, 1619
    • Spec. Hospital of Ophthalm. for Active Treatment Visus
  • Varna, Bulgaria, 9000
    • Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna
• Czechia
  • Ostrava, Czechia, 708 52
    • Fakultni Nemocnice Ostrava
  • Praha 2, Czechia, 12808
    • Vseobecna fakultni nemocnice v Praze
• Greece
  • Athens, Greece, 11527
    • P & A KYRIAKOU Children's Hospital
  • Ioannina, Greece, 45500
    • University General Hospital of Ioannina
  • Thessaloniki, Greece, 56403
    • Papageorgiou General Hospital of Thessaloniki
• Hungary
  • Budapest, Hungary, 1125
    • EKBC, Uj Szent Janos Korhaz es Szakrendelo
• Israel
  • Rehovot, Israel, 7661041
    • Kaplan Medical Center
• Italy
  • Lazio
    • Roma, Lazio, Italy, 00165
      • IRCCS Ospedale Pediatrico Bambino Gesu
    • Roma, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli Irccs
  • Lombardia
    • Milano, Lombardia, Italy, 20122
      • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
  • Umbria
    • Perugia, Umbria, Italy, 06129
      • A.O. di Perugia
• Japan
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 807-8556
      • Hospital of the University of Occupational and Environmental Health, Japan
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Okinawa
    • Shimajiri-gun, Okinawa, Japan, 901-1193
      • Okinawa Prefectural Nanbu Medical Center and Children's MC
  • Osaka
    • Osakasayama, Osaka, Japan, 589-8511
      • Kindai University Hospital
  • Tokyo
    • Fuchu, Tokyo, Japan, 183-8561
      • Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center
    • Sumida-ku, Tokyo, Japan, 130-8575
      • Tokyo Metropolitan Bokutoh Hospital
    • Toshima-ku, Tokyo, Japan, 170-8476
      • Tokyo Metropolitan Ohtsuka Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Chungcheongnamdo
    • Cheonan, Chungcheongnamdo, Korea, Republic of, 31151
      • Soon Chun Hyang University Cheonan Hospital
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur
• Netherlands
  • Veldhoven, Netherlands, 5504 DB
    • Maxima Medisch Centrum, locatie Veldhoven
• Portugal
  • Lisboa, Portugal, 1449-005
    • Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
  • Lisboa
    • Amadora, Lisboa, Portugal, 2720-276
      • Hospital Prof. Dr. Fernando Fonseca
• Romania
  • Iasi, Romania, 700038
    • Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda"
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400006
      • Clinical Emergency County Hospital
• Russian Federation
  • Kaluga, Russian Federation, 248007
    • FSAI NMRC IRTC "Eye Microsurgery", Kaluga's Branch
  • Moscow, Russian Federation, 119620
    • FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo"
  • Saint-Petersburg, Russian Federation, 198205
    • City Children Hospital ¿1
• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital
• Slovakia
  • Bratislava, Slovakia, 833 41
    • Narodny ustav detskych chorob
• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital la Paz - oftalmologia
  • Málaga
    • Malaga, Málaga, Spain, 29010
      • Hospital Regional de Malaga | Oftalmologia
• Sweden
  • Göteborg, Sweden
    • Sahlgrenska Universitetssjukhuset
• Taiwan
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 807377
      • Kaohsiung Medical University Chung-Ho Memorial Hospital
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe Universitesi Tip Fakultesi
  • Ankara, Turkey, 06500
    • Gazi Universitesi Tip Fakultesi
  • Antalya, Turkey, 07100
    • Saglik Bilimleri Universitesi Antalya EA Hastanesi
  • Eskisehir, Turkey, 26480
    • Eskisehir Osmangazi Universitesi Tip Fakultesi
  • Yüregir, Turkey, 1370
    • S.B.U. Adana Sehir Egitim ve Arastirma Hastanesi
• Ukraine
  • Odesa, Ukraine, 65061
    • The Filatov Institute of Eye Diseases and Tissue Therapy
• United Kingdom
  • Birmingham, United Kingdom, B15 2TG
    • Birmingham Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aflibercept arm; No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.	Drug: Eylea (Aflibercept, BAY86-5321); Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection.
Active Comparator: Laser photocoagulation arm; No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.	Procedure: Laser photocoagulation; Treatment administered in 20090. Transpupillary conventional laser ablative therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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		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.

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2020
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Retinal Diseases; Premature Birth; Retinopathy of Prematurity; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: 20275; 2018-003180-54 (EudraCT Number); 2023-504207-89-00 (Other Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No