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

Primary Purpose

Retinopathy of Prematurity (ROP)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eylea (Aflibercept, BAY86-5321)
Laser photocoagulation
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Retinopathy of Prematurity (ROP)

Eligibility Criteria

undefined - 13 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Público Descentralizado "Dr. Guillermo Rawson"
  • AZ Sint-Jan Brugge-Oostende | Sint-Jan - Cardiology
  • Hospital das Clínicas de Botucatu - UNESP Botucatu
  • Unifesp/Epm
  • UMHAT Sveti Georgi
  • Acibadem City Clinic Multiprofile Hospital for Active Treatm
  • Spec. Hospital of Ophthalm. for Active Treatment Visus
  • Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna
  • Fakultni nemocnice Ostrava
  • Vseobecna fakultni nemocnice v Praze
  • P & A KYRIAKOU Children's Hospital
  • University General Hospital of Ioannina
  • Papageorgiou General Hospital of Thessaloniki
  • EKBC, Uj Szent Janos Korhaz es Szakrendelo
  • Kaplan Medical Center
  • IRCCS Ospedale Pediatrico Bambino Gesù
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • A.O. di Perugia
  • Hospital of the University of Occupational and Environmental Health, Japan
  • Kurume University Hospital
  • Okinawa Prefectural Nanbu Medical Center and Children's MC
  • Kindai University Hospital
  • Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center
  • Tokyo Metropolitan Bokutoh Hospital
  • Tokyo Metropolitan Ohtsuka Hospital
  • Kyushu University Hospital
  • Fukuoka University Hospital
  • Fukushima Medical University Hospital
  • Soon Chun Hyang University Cheonan Hospital
  • Asan Medical Center
  • Hospital Kuala Lumpur
  • Maxima Medisch Centrum, locatie Veldhoven
  • Hospital Prof. Dr. Fernando Fonseca
  • Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
  • Clinical Emergency County Hospital
  • Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda"
  • FSAI NMRC IRTC "Eye Microsurgery", Kaluga's Branch
  • FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo"
  • City Children Hospital ¿1
  • KK Women's and Children's Hospital
  • Narodny ustav detskych chorob
  • Hospital Regional de Malaga | Oftalmologia
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario "La Paz"
  • Sahlgrenska Universitetssjukhuset
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Mackay Memorial Hospital
  • S.B.U. Adana Sehir Egitim ve Arastirma Hastanesi
  • Hacettepe Universitesi Tip Fakultesi
  • Gazi Universitesi Tip Fakultesi
  • Saglik Bilimleri Universitesi Antalya EA Hastanesi
  • Eskisehir Osmangazi Universitesi Tip Fakultesi
  • The Filatov Institute of Eye Diseases and Tissue Therapy
  • Birmingham Womens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aflibercept arm

Laser photocoagulation arm

Arm Description

No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.

No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.

Outcomes

Primary Outcome Measures

Binocular best-corrected visual acuity in Snellen equivalent
Proportion of subjects with ocular AEs and SAEs
AE: adverse event SAE: serious adverse event
Proportion of subjects with systemic AEs and SAEs

Secondary Outcome Measures

Proportion of subjects developing unfavorable ocular structural outcome
Unfavorable ocular structural outcome include: retinal detachment, macular dragging, macular fold, retrolental opacity
Proportion of subjects with absence of active ROP and unfavorable structural outcomes
Best-corrected visual acuity in each eye
Refractive spherical equivalent in each eye
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.
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.
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.
Proportion of subjects with recurrence of ROP
Proportion of subjects requiring treatment for ROP
Proportion of subjects requiring ophthalmological treatment

Full Information

First Posted
June 28, 2019
Last Updated
October 4, 2023
Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04015180
Brief Title
Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 18, 2020 (Actual)
Primary Completion Date
July 3, 2025 (Anticipated)
Study Completion Date
July 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity (ROP)

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept arm
Arm Type
Experimental
Arm Description
No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.
Arm Title
Laser photocoagulation arm
Arm Type
Active Comparator
Arm Description
No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.
Intervention Type
Drug
Intervention Name(s)
Eylea (Aflibercept, BAY86-5321)
Intervention Description
Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection.
Intervention Type
Procedure
Intervention Name(s)
Laser photocoagulation
Intervention Description
Treatment administered in 20090. Transpupillary conventional laser ablative therapy
Primary Outcome Measure Information:
Title
Binocular best-corrected visual acuity in Snellen equivalent
Time Frame
At 5 years of age.
Title
Proportion of subjects with ocular AEs and SAEs
Description
AE: adverse event SAE: serious adverse event
Time Frame
Up to 5 years of age.
Title
Proportion of subjects with systemic AEs and SAEs
Time Frame
Up to 5 years of age.
Secondary Outcome Measure Information:
Title
Proportion of subjects developing unfavorable ocular structural outcome
Description
Unfavorable ocular structural outcome include: retinal detachment, macular dragging, macular fold, retrolental opacity
Time Frame
At 1,3 and 5 years of age.
Title
Proportion of subjects with absence of active ROP and unfavorable structural outcomes
Time Frame
At 1 year of age.
Title
Best-corrected visual acuity in each eye
Time Frame
At 3 and 5 years of age.
Title
Refractive spherical equivalent in each eye
Time Frame
At 3 and 5 years of age
Title
Neurodevelopmental outcomes using BSID-III
Description
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.
Time Frame
At 2 years of age
Title
Neurodevelopmental outcomes using WPPSI-IV
Description
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.
Time Frame
At 5 years of age
Title
Neurodevelopmental outcomes using VABS-II
Description
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.
Time Frame
At 2 and 5 years of age
Title
Proportion of subjects with recurrence of ROP
Time Frame
At 3 and 5 years of age.
Title
Proportion of subjects requiring treatment for ROP
Time Frame
Up to 5 years of age.
Title
Proportion of subjects requiring ophthalmological treatment
Time Frame
Up to 5 years of age.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
13 Months
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital Público Descentralizado "Dr. Guillermo Rawson"
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
AZ Sint-Jan Brugge-Oostende | Sint-Jan - Cardiology
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Hospital das Clínicas de Botucatu - UNESP Botucatu
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618 970
Country
Brazil
Facility Name
Unifesp/Epm
City
Sao Paulo
ZIP/Postal Code
04023-061
Country
Brazil
Facility Name
UMHAT Sveti Georgi
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Acibadem City Clinic Multiprofile Hospital for Active Treatm
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Spec. Hospital of Ophthalm. for Active Treatment Visus
City
Sofia
ZIP/Postal Code
1619
Country
Bulgaria
Facility Name
Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
P & A KYRIAKOU Children's Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital of Ioannina
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Papageorgiou General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
Facility Name
EKBC, Uj Szent Janos Korhaz es Szakrendelo
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7661041
Country
Israel
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesù
City
Roma
State/Province
Lazio
ZIP/Postal Code
00165
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
A.O. di Perugia
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06129
Country
Italy
Facility Name
Hospital of the University of Occupational and Environmental Health, Japan
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Okinawa Prefectural Nanbu Medical Center and Children's MC
City
Shimajiri-gun
State/Province
Okinawa
ZIP/Postal Code
901-1193
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center
City
Fuchu
State/Province
Tokyo
ZIP/Postal Code
183-8561
Country
Japan
Facility Name
Tokyo Metropolitan Bokutoh Hospital
City
Sumida-ku
State/Province
Tokyo
ZIP/Postal Code
130-8575
Country
Japan
Facility Name
Tokyo Metropolitan Ohtsuka Hospital
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
170-8476
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Soon Chun Hyang University Cheonan Hospital
City
Cheonan
State/Province
Chungcheongnamdo
ZIP/Postal Code
31151
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Maxima Medisch Centrum, locatie Veldhoven
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Facility Name
Hospital Prof. Dr. Fernando Fonseca
City
Amadora
State/Province
Lisboa
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
City
Lisboa
ZIP/Postal Code
1449-005
Country
Portugal
Facility Name
Clinical Emergency County Hospital
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400006
Country
Romania
Facility Name
Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda"
City
Iasi
ZIP/Postal Code
700038
Country
Romania
Facility Name
FSAI NMRC IRTC "Eye Microsurgery", Kaluga's Branch
City
Kaluga
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo"
City
Moscow
ZIP/Postal Code
119620
Country
Russian Federation
Facility Name
City Children Hospital ¿1
City
Saint-Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
Narodny ustav detskych chorob
City
Bratislava
ZIP/Postal Code
833 41
Country
Slovakia
Facility Name
Hospital Regional de Malaga | Oftalmologia
City
Malaga
State/Province
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario "La Paz"
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
Country
Sweden
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung City
State/Province
Kaohsiung
ZIP/Postal Code
807377
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
S.B.U. Adana Sehir Egitim ve Arastirma Hastanesi
City
Adana
ZIP/Postal Code
4522
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Gazi Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Saglik Bilimleri Universitesi Antalya EA Hastanesi
City
Antalya
ZIP/Postal Code
07100
Country
Turkey
Facility Name
Eskisehir Osmangazi Universitesi Tip Fakultesi
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
The Filatov Institute of Eye Diseases and Tissue Therapy
City
Odesa
ZIP/Postal Code
65061
Country
Ukraine
Facility Name
Birmingham Womens Hospital
City
Birmingham
ZIP/Postal Code
B15 2TG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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