search
Back to results

Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy (FIREFLEYE)

Primary Purpose

Retinopathy of Prematurity (ROP)

Status
Completed
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 treatment trial for Retinopathy of Prematurity (ROP)

Eligibility Criteria

undefined - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gestational age at birth ≤ 32 weeks or birth weight ≤ 1500 g

  • Subjects with treatment-naïve ROP classified according to the International Classification for ROP in at least one eye as:

    • Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or
    • Zone II Stage 2 plus or 3 plus, or
    • Aggressive posterior retinopathy of prematurity (AP-ROP)
  • Weight at baseline (day of treatment) ≥ 800 g
  • 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:

  • Known or suspected chromosomal abnormality, genetic disorder or syndrome
  • Previous exposure to any IVT or systemic anti-vascular endothelial growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during breastfeeding
  • Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic nerve function, severe hydrocephalus with significantly increased intracranial pressure)
  • Pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a NICU specialist and a study ophthalmologist
  • Presence of active ocular infection within 5 days of the first treatment
  • Advanced stages of ROP with partial or complete retinal detachment (ROP Stages 4 and 5)
  • ROP involving only Zone III
  • Ocular abnormalities that may interfere with the administration of study intervention or assessment of the study primary endpoint
  • Postnatal treatment with oral or intravenous corticosteroids at an equivalent dose of prednisone ≥ 1 mg/kg/day for > 2 weeks within 14 days of the first study intervention
  • Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative laser therapy, cryotherapy, and vitrectomy)
  • Participation of the subject or the mother in other clinical trials requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening, or within 30 days or 5 half-lives of administration of the previous study drug, whichever is longer

Sites / Locations

  • Many Locations
  • Hospital Público Descentralizado "Dr. Guillermo Rawson"
  • Kepler Universitätsklinikum Campus III
  • Many Locations
  • AZ St-Jan Brugge Oostende AV
  • Many Locations
  • Hospital das Clínicas de Botucatu - UNESP Botucatu
  • Many Locations
  • Unifesp/Epm
  • Many Locations
  • UMHAT Sveti Georgi
  • Acibadem City Clinic Multiprofile Hospital for Active Treatm
  • II SOGHAT Sheinovo
  • SHOGAT Prof Dimitar Stamatov
  • Many Locations
  • Fakultni nemocnice Ostrava
  • Vseobecna fakultni nemocnice v Praze
  • P & A KYRIAKOU Children's Hospital
  • University General Hospital of Ioannina
  • Many Locations
  • Papageorgiou General Hospital of Thessaloniki
  • Queen Mary Hospital
  • Many Locations
  • EKBC, Uj Szent Janos Korhaz es Szakrendelo
  • Many Locations
  • Many Locations
  • 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
  • Many Locations
  • University of Occupational and Environmental Health
  • Kurume University Hospital
  • Okinawa Prefectural Nanbu Medical Center and Children's MC
  • Tokyo Metropolitan Children's Medical Center
  • Showa University Hospital
  • Tokyo Metropolitan Bokutoh Hospital
  • Tokyo Metropolitan Ohtsuka Hospital
  • Kyushu University Hospital
  • Fukuoka University Hospital
  • Fukushima Medical University Hospital
  • Many Locations
  • Saitama Children's Medical Center
  • Soon Chun Hyang University Cheonan Hospital
  • Many Locations
  • Asan Medical Center
  • Samsung Medical Center
  • Hospital Kuala Lumpur
  • Many Locations
  • Many Locations
  • Maxima Medisch Centrum, locatie Veldhoven
  • Many Locations
  • Ginekologiczno-Polozniczy SK UM im. K. Marcinkowskiego
  • Hospital Prof. Dr. Fernando Fonseca
  • CHLO - Hospital Sao Francisco Xavier
  • Many Locations
  • Clinical Emergency County Hospital
  • Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda"
  • Many Locations
  • FSAI NMRC IRTC "Eye Microsurgery", Kaluga's Branch
  • Russian National Scientific Medical University
  • FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo"
  • Many Locations
  • Pediatric Medical University
  • City Children Hospital ¿1
  • Many Locations
  • KK Women's and Children's Hospital
  • Narodny ustav detskych chorob
  • Many Locations
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario "La Paz"
  • Many Locations
  • Hospital Regional de Málaga
  • Sahlgrenska Universitetssjukhuset
  • Many Locations
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Many Locations
  • Mackay Memorial Hospital
  • S.B.U. Adana Sehir Egitim ve Arastirma Hastanesi
  • Hacettepe Universitesi Tip Fakultesi
  • Baskent Universitesi Tip Fakultesi Hastanesi
  • Gazi Universitesi Tip Fakultesi
  • Saglik Bilimleri Universitesi Antalya EA Hastanesi
  • Eskisehir Osmangazi Universitesi Tip Fakultesi
  • Many Locations
  • Many Locations
  • MI"Odesa Regional Children's Clinical Hospital"
  • Birmingham Womens Hospital
  • Many Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aflibercept arm

Laser photocoagulation arm

Arm Description

Subjects randomized to aflibercept will receive a intravitreal (IVT) injection of Dose A aflibercept per eligible eye at baseline and, if needed, up to a defined number of additional injections in each eye.

Subjects randomized to laser photocoagulation will receive treatment in each eligible eye at baseline. Retreatments may be administered if needed.

Outcomes

Primary Outcome Measures

Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes
Active ROP was defined as ROP requiring treatment. Unfavorable structural outcomes included retinal detachment, macular dragging, macular fold, or retrolental opacity.

Secondary Outcome Measures

Proportion of Participants Requiring Intervention With a Second Treatment Modality
A second treatment modality for ROP was either rescue treatment or any other surgical or nonsurgical treatment for ROP (e.g. IVT anti-VEGF injection, ablative laser therapy, cryotherapy, or vitrectomy) captured as concomitant medication or surgery after study start.
Proportion of Participants With Recurrence of ROP
Participants with recurrence of ROP were defined as subjects requiring re-treatment or rescue treatment after in the past the absence of treatment-requiring active ROP had been confirmed by the investigator.
Exploration of ROP Activity Scale Proposed by the International Neonatal Consortium
Eyes were evaluated for change in ROP activity scale proposed by the International Neonatal Consortium (2018). ROP Activity Scale value range is from 0 to 22. Value 0 to 7 are considered mild, 8 to 12 are moderate, and 13 to 22 are severe. Value 0 means the best and value 22 means the worst. Eyes evaluation was done at baseline and each visit.
Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs)
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that was observed or reported after the first and not later than 30 days after the last administration of study treatment. Participants treated after week 21 were followed-up for adverse events up to week 28. Ocular TEAEs in treated eyes only were reported
Percentage of Participants With Ocular Serious Adverse Events (SAEs)
Participants treated after week 21 were followed-up for adverse events up to week 28. Ocular SAEs in treated eyes only were reported.
Percentage of Participants With Systemic TEAEs
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that was observed or reported after the first and not later than 30 days after the last administration of study treatment. Participants treated after week 21 were followed-up for adverse events up to week 28. Systemic TEAEs only were reported.
Percentage of Participants With Systemic SAEs
Participants treated after week 21 were followed-up for adverse events up to week 28. Systemic SAEs only were reported.
Concentrations of Free Aflibercept in Plasma
Blood samples for determination of aflibercept concentrations in plasma were collected in the aflibercept 0.4 mg arm at Day 1 (within 24 hours after injection), and at weeks 2 and 4, and if feasible also at weeks 8, 12 and 24. Statistics for week 8, 12, 24 not calculated as > 1/3 of the concentrations were below the lower limit of quantification. Free Aflibercept Concentrations in Plasma were only measured in the Aflibercept 0.4 mg treatment arm.
Number of Participants With Anti-drug Antibodies (ADA)
Immunogenicity was characterized by anti-drug antibody (ADA) responses in patients in the aflibercept 0.4 mg arm. Serum samples were taken at baseline prior to the injection and at 12 weeks after injection. ADA titers were summarized for 3 categories: Low (titer <1,000); Moderate (1,000 ≤ titer ≤ 10,000); High (titer >10,000). ADA in serum were only measured in the Aflibercept 0.4 mg treatment arm.
Number of Participants With Potential Neutralizing Antibodies (NAb)
NAb status was evaluated for the samples that were positive in the ADA assay and had sufficient volume to analyze. NAb were only measured in participants with positive ADA in the Aflibercept 0.4 mg treatment arm
Number of Aflibercept Administrations
Total number of injections in both eyes.
Number of Laser Treatments
Total number of laser treatment in both eyes. If multiple sessions of laser treatment were necessary within 1 week from baseline, they were counted as a single treatment.

Full Information

First Posted
June 28, 2019
Last Updated
May 4, 2022
Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT04004208
Brief Title
Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
Acronym
FIREFLEYE
Official Title
Open-label, Randomized, Two-Arm, Controlled Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal (IVT) Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity (ROP)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
February 12, 2021 (Actual)
Study Completion Date
February 12, 2021 (Actual)

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
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.

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
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept arm
Arm Type
Experimental
Arm Description
Subjects randomized to aflibercept will receive a intravitreal (IVT) injection of Dose A aflibercept per eligible eye at baseline and, if needed, up to a defined number of additional injections in each eye.
Arm Title
Laser photocoagulation arm
Arm Type
Active Comparator
Arm Description
Subjects randomized to laser photocoagulation will receive treatment in each eligible eye at baseline. Retreatments may be administered if needed.
Intervention Type
Drug
Intervention Name(s)
Eylea (Aflibercept, BAY86-5321)
Intervention Description
Solution in a sterile glass vial, Dose A, IVT injection.
Intervention Type
Procedure
Intervention Name(s)
Laser photocoagulation
Intervention Description
Transpupillary conventional laser ablative therapy
Primary Outcome Measure Information:
Title
Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes
Description
Active ROP was defined as ROP requiring treatment. Unfavorable structural outcomes included retinal detachment, macular dragging, macular fold, or retrolental opacity.
Time Frame
At 24 weeks after starting study treatment
Secondary Outcome Measure Information:
Title
Proportion of Participants Requiring Intervention With a Second Treatment Modality
Description
A second treatment modality for ROP was either rescue treatment or any other surgical or nonsurgical treatment for ROP (e.g. IVT anti-VEGF injection, ablative laser therapy, cryotherapy, or vitrectomy) captured as concomitant medication or surgery after study start.
Time Frame
From baseline (treatment) up to week 24.
Title
Proportion of Participants With Recurrence of ROP
Description
Participants with recurrence of ROP were defined as subjects requiring re-treatment or rescue treatment after in the past the absence of treatment-requiring active ROP had been confirmed by the investigator.
Time Frame
From baseline (treatment) up to week 24.
Title
Exploration of ROP Activity Scale Proposed by the International Neonatal Consortium
Description
Eyes were evaluated for change in ROP activity scale proposed by the International Neonatal Consortium (2018). ROP Activity Scale value range is from 0 to 22. Value 0 to 7 are considered mild, 8 to 12 are moderate, and 13 to 22 are severe. Value 0 means the best and value 22 means the worst. Eyes evaluation was done at baseline and each visit.
Time Frame
From baseline (treatment) up to week 24.
Title
Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs)
Description
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that was observed or reported after the first and not later than 30 days after the last administration of study treatment. Participants treated after week 21 were followed-up for adverse events up to week 28. Ocular TEAEs in treated eyes only were reported
Time Frame
From baseline (treatment) up to week 24
Title
Percentage of Participants With Ocular Serious Adverse Events (SAEs)
Description
Participants treated after week 21 were followed-up for adverse events up to week 28. Ocular SAEs in treated eyes only were reported.
Time Frame
From baseline (treatment) up to week 24
Title
Percentage of Participants With Systemic TEAEs
Description
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that was observed or reported after the first and not later than 30 days after the last administration of study treatment. Participants treated after week 21 were followed-up for adverse events up to week 28. Systemic TEAEs only were reported.
Time Frame
From baseline (treatment) up to week 24
Title
Percentage of Participants With Systemic SAEs
Description
Participants treated after week 21 were followed-up for adverse events up to week 28. Systemic SAEs only were reported.
Time Frame
From baseline (treatment) up to week 24
Title
Concentrations of Free Aflibercept in Plasma
Description
Blood samples for determination of aflibercept concentrations in plasma were collected in the aflibercept 0.4 mg arm at Day 1 (within 24 hours after injection), and at weeks 2 and 4, and if feasible also at weeks 8, 12 and 24. Statistics for week 8, 12, 24 not calculated as > 1/3 of the concentrations were below the lower limit of quantification. Free Aflibercept Concentrations in Plasma were only measured in the Aflibercept 0.4 mg treatment arm.
Time Frame
From Day 1 up to week 24.
Title
Number of Participants With Anti-drug Antibodies (ADA)
Description
Immunogenicity was characterized by anti-drug antibody (ADA) responses in patients in the aflibercept 0.4 mg arm. Serum samples were taken at baseline prior to the injection and at 12 weeks after injection. ADA titers were summarized for 3 categories: Low (titer <1,000); Moderate (1,000 ≤ titer ≤ 10,000); High (titer >10,000). ADA in serum were only measured in the Aflibercept 0.4 mg treatment arm.
Time Frame
Baseline (treatment) and 12 weeks after aflibercept injection
Title
Number of Participants With Potential Neutralizing Antibodies (NAb)
Description
NAb status was evaluated for the samples that were positive in the ADA assay and had sufficient volume to analyze. NAb were only measured in participants with positive ADA in the Aflibercept 0.4 mg treatment arm
Time Frame
At 12 weeks after aflibercept injection
Title
Number of Aflibercept Administrations
Description
Total number of injections in both eyes.
Time Frame
From baseline (treatment) up to week 24.
Title
Number of Laser Treatments
Description
Total number of laser treatment in both eyes. If multiple sessions of laser treatment were necessary within 1 week from baseline, they were counted as a single treatment.
Time Frame
From baseline (treatment) up to week 24.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age at birth ≤ 32 weeks or birth weight ≤ 1500 g Subjects with treatment-naïve ROP classified according to the International Classification for ROP in at least one eye as: Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or Zone II Stage 2 plus or 3 plus, or Aggressive posterior retinopathy of prematurity (AP-ROP) Weight at baseline (day of treatment) ≥ 800 g 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: Known or suspected chromosomal abnormality, genetic disorder or syndrome Previous exposure to any IVT or systemic anti-vascular endothelial growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during breastfeeding Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic nerve function, severe hydrocephalus with significantly increased intracranial pressure) Pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a NICU specialist and a study ophthalmologist Presence of active ocular infection within 5 days of the first treatment Advanced stages of ROP with partial or complete retinal detachment (ROP Stages 4 and 5) ROP involving only Zone III Ocular abnormalities that may interfere with the administration of study intervention or assessment of the study primary endpoint Postnatal treatment with oral or intravenous corticosteroids at an equivalent dose of prednisone ≥ 1 mg/kg/day for > 2 weeks within 14 days of the first study intervention Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative laser therapy, cryotherapy, and vitrectomy) Participation of the subject or the mother in other clinical trials requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening, or within 30 days or 5 half-lives of administration of the previous study drug, whichever is longer
Facility Information:
Facility Name
Many Locations
City
Multiple Locations
Country
Argentina
Facility Name
Hospital Público Descentralizado "Dr. Guillermo Rawson"
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
Kepler Universitätsklinikum Campus III
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Many Locations
City
Multiple Locations
Country
Austria
Facility Name
AZ St-Jan Brugge Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Many Locations
City
Multiple Locations
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
Many Locations
City
Multiple Locations
Country
Brazil
Facility Name
Unifesp/Epm
City
Sao Paulo
ZIP/Postal Code
04023-061
Country
Brazil
Facility Name
Many Locations
City
Multiple Locations
Country
Bulgaria
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
II SOGHAT Sheinovo
City
Sofia
ZIP/Postal Code
1504
Country
Bulgaria
Facility Name
SHOGAT Prof Dimitar Stamatov
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Many Locations
City
Multiple Locations
Country
Czechia
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
Many Locations
City
Multiple Locations
Country
Greece
Facility Name
Papageorgiou General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Many Locations
City
Multiple Locations
Country
Hong Kong
Facility Name
EKBC, Uj Szent Janos Korhaz es Szakrendelo
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Many Locations
City
Multiple Locations
Country
Hungary
Facility Name
Many Locations
City
Multiple Locations
Country
Israel
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
Many Locations
City
Multiple Locations
Country
Italy
Facility Name
University of Occupational and Environmental Health
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
Tokyo Metropolitan Children's Medical Center
City
Fuchu
State/Province
Tokyo
ZIP/Postal Code
183-8561
Country
Japan
Facility Name
Showa University Hospital
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
142-8666
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
Many Locations
City
Multiple Locations
Country
Japan
Facility Name
Saitama Children's Medical Center
City
Saitama
ZIP/Postal Code
330-8777
Country
Japan
Facility Name
Soon Chun Hyang University Cheonan Hospital
City
Cheonan-si
State/Province
Chungcheongnamdo
Country
Korea, Republic of
Facility Name
Many Locations
City
Multiple Locations
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Many Locations
City
Multiple Locations
Country
Malaysia
Facility Name
Many Locations
City
Multiple Locations
Country
Netherlands
Facility Name
Maxima Medisch Centrum, locatie Veldhoven
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Facility Name
Many Locations
City
Multiple Locations
Country
Poland
Facility Name
Ginekologiczno-Polozniczy SK UM im. K. Marcinkowskiego
City
Poznan
ZIP/Postal Code
60-535
Country
Poland
Facility Name
Hospital Prof. Dr. Fernando Fonseca
City
Amadora
State/Province
Lisboa
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
CHLO - Hospital Sao Francisco Xavier
City
Lisboa
ZIP/Postal Code
1449-005
Country
Portugal
Facility Name
Many Locations
City
Multiple Locations
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
Many Locations
City
Multiple Locations
Country
Romania
Facility Name
FSAI NMRC IRTC "Eye Microsurgery", Kaluga's Branch
City
Kaluga
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
Russian National Scientific Medical University
City
Moscow
ZIP/Postal Code
117997
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
Many Locations
City
Multiple Locations
Country
Russian Federation
Facility Name
Pediatric Medical University
City
Saint-Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
City Children Hospital ¿1
City
Saint-Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Many Locations
City
Multiple Locations
Country
Singapore
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
Many Locations
City
Multiple Locations
Country
Slovakia
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
Many Locations
City
Multiple Locations
Country
Spain
Facility Name
Hospital Regional de Málaga
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
Country
Sweden
Facility Name
Many Locations
City
Multiple Locations
Country
Sweden
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Many Locations
City
Multiple Locations
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
Baskent Universitesi Tip Fakultesi Hastanesi
City
Ankara
ZIP/Postal Code
06490
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
Many Locations
City
Multiple Locations
Country
Turkey
Facility Name
Many Locations
City
Multiple Locations
Country
Ukraine
Facility Name
MI"Odesa Regional Children's Clinical Hospital"
City
Odesa
ZIP/Postal Code
65031
Country
Ukraine
Facility Name
Birmingham Womens Hospital
City
Birmingham
ZIP/Postal Code
B15 2TG
Country
United Kingdom
Facility Name
Many Locations
City
Multiple Locations
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Citations:
PubMed Identifier
35881122
Citation
Stahl A, Sukgen EA, Wu WC, Lepore D, Nakanishi H, Mazela J, Moshfeghi DM, Vitti R, Athanikar A, Chu K, Iveli P, Zhao F, Schmelter T, Leal S, Kofuncu E, Azuma N; FIREFLEYE Study Group. Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial. JAMA. 2022 Jul 26;328(4):348-359. doi: 10.1001/jama.2022.10564.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
URL
http://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products

Learn more about this trial

Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy

We'll reach out to this number within 24 hrs