Retinopathy of Prematurity (ROP)Phase 3FIREFLEYENCT04004208
Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
A Phase 3 study testing Eylea (Aflibercept, BAY86-5321) and Laser photocoagulation in people with Retinopathy of Prematurity (ROP), run by Bayer at 90 sites in 27 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Retinopathy of Prematurity (ROP)
- What is being tested?
- Eylea (Aflibercept, BAY86-5321) and Laser photocoagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 90 sitesin 27 countries
- Study dates
- 25 Sep 2019to 12 Feb 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
90 sites in 27 countries.
90 sites in 27 countries
Japan12 sites
Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, 183-8561
Kyushu University Hospital
Fukuoka, 812-8582
Fukuoka University Hospital
Fukuoka, 814-0180
Fukushima Medical University Hospital
Fukushima, 960-1295
University of Occupational and Environmental Health
Kitakyushu, Fukuoka, 807-8556
Kurume University Hospital
Kurume, Fukuoka, 830-0011
Many Locations
Multiple Locations
Saitama Children's Medical Center
Saitama, 330-8777
Okinawa Prefectural Nanbu Medical Center and Children's MC
Shimajiri-gun, Okinawa, 901-1193
Showa University Hospital
Shinagawa, Tokyo, 142-8666
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku, Tokyo, 130-8575
Tokyo Metropolitan Ohtsuka Hospital
Toshima-ku, Tokyo, 170-8476
Turkey (Türkiye)7 sites
S.B.U. Adana Sehir Egitim ve Arastirma Hastanesi
Adana, 4522
Hacettepe Universitesi Tip Fakultesi
Ankara, 06100
Baskent Universitesi Tip Fakultesi Hastanesi
Ankara, 06490
Gazi Universitesi Tip Fakultesi
Ankara, 06500
Saglik Bilimleri Universitesi Antalya EA Hastanesi
Antalya, 07100
Eskisehir Osmangazi Universitesi Tip Fakultesi
Eskişehir, 26480
Many Locations
Multiple Locations
Russia6 sites
FSAI NMRC IRTC "Eye Microsurgery", Kaluga's Branch
Kaluga, 248007
Russian National Scientific Medical University
Moscow, 117997
FGBUZ "NPC of special children care n.a. Voino-Yaseneckogo"
Moscow, 119620
Many Locations
Multiple Locations
Pediatric Medical University
Saint Petersburg, 194100
City Children Hospital ¿1
Saint Petersburg, 198205
Bulgaria5 sites
Many Locations
Multiple Locations
UMHAT Sveti Georgi
Plovdiv, 4002
Acibadem City Clinic Multiprofile Hospital for Active Treatm
Sofia, 1407
II SOGHAT Sheinovo
Sofia, 1504
SHOGAT Prof Dimitar Stamatov
Varna, 9000
Italy5 sites
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Many Locations
Multiple Locations
A.O. di Perugia
Perugia, Umbria, 06129
IRCCS Ospedale Pediatrico Bambino Gesù
Rome, Lazio, 00165
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168
Greece4 sites
P & A KYRIAKOU Children's Hospital
Athens, 11527
University General Hospital of Ioannina
Ioannina, 45500
Many Locations
Multiple Locations
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 56403
South Korea4 sites
Soon Chun Hyang University Cheonan Hospital
Cheonan-si, Chungcheongnam-do
Many Locations
Multiple Locations
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Spain4 sites
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario "La Paz"
Madrid, 28046
Hospital Regional de Málaga
Málaga, 29011
Many Locations
Multiple Locations
Brazil3 sites
Hospital das Clínicas de Botucatu - UNESP Botucatu
Botucatu, São Paulo, 18618 970
Many Locations
Multiple Locations
Unifesp/Epm
São Paulo, 04023-061
Czechia3 sites
Many Locations
Multiple Locations
Fakultni nemocnice Ostrava
Ostrava, 708 52
Vseobecna fakultni nemocnice v Praze
Prague, 12808
Portugal3 sites
Hospital Prof. Dr. Fernando Fonseca
Amadora, Lisbon District, 2720-276
CHLO - Hospital Sao Francisco Xavier
Lisbon, 1449-005
Many Locations
Multiple Locations
Romania3 sites
Clinical Emergency County Hospital
Cluj-Napoca, Cluj, 400006
Spitalul Clinic de Obstretica si Ginecologie "Cuza Voda"
Iași, 700038
Many Locations
Multiple Locations
Taiwan3 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Many Locations
Multiple Locations
Mackay Memorial Hospital
Taipei, 10449
Argentina2 sites
Many Locations
Multiple Locations
Hospital Público Descentralizado "Dr. Guillermo Rawson"
San Juan, 5400
Austria2 sites
Kepler Universitätsklinikum Campus III
Linz, 4021
Many Locations
Multiple Locations
Belgium2 sites
AZ St-Jan Brugge Oostende AV
Bruges, 8000
Many Locations
Multiple Locations
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
Many Locations
Multiple Locations
Hungary2 sites
EKBC, Uj Szent Janos Korhaz es Szakrendelo
Budapest, 1125
Many Locations
Multiple Locations
Israel2 sites
Many Locations
Multiple Locations
Kaplan Medical Center
Rehovot, 7661041
Malaysia2 sites
Hospital Kuala Lumpur
Kuala Lumpur, 50586
Many Locations
Multiple Locations
Netherlands2 sites
Many Locations
Multiple Locations
Maxima Medisch Centrum, locatie Veldhoven
Veldhoven, 5504 DB
Poland2 sites
Many Locations
Multiple Locations
Ginekologiczno-Polozniczy SK UM im. K. Marcinkowskiego
Poznan, 60-535
Singapore2 sites
Many Locations
Multiple Locations
KK Women's and Children's Hospital
Singapore, 229899
Slovakia2 sites
Narodny ustav detskych chorob
Bratislava, 833 41
Many Locations
Multiple Locations
Sweden2 sites
Sahlgrenska Universitetssjukhuset
Gothenburg
Many Locations
Multiple Locations
Ukraine2 sites
Many Locations
Multiple Locations
MI"Odesa Regional Children's Clinical Hospital"
Odesa, 65031
United Kingdom2 sites
Birmingham Womens Hospital
Birmingham, B15 2TG
Many Locations
Multiple Locations
About this study
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)
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.
- Conditions
- Retinopathy of Prematurity (ROP)
- Being tested
- Eylea (Aflibercept, BAY86-5321), Laser photocoagulation
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eylea (Aflibercept, BAY86-5321)Drug
Solution in a sterile glass vial, Dose A, IVT injection.
Laser photocoagulationProcedure or surgery
Transpupillary conventional laser ablative therapy
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept arm | Experimental | 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. Receives: Drug: Eylea (Aflibercept, BAY86-5321) |
| Laser photocoagulation arm | Active comparator | Subjects randomized to laser photocoagulation will receive treatment in each eligible eye at baseline. Retreatments may be administered if needed. Receives: Procedure: Laser photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 24 weeks after starting study treatment
Secondary outcomes (12)
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.
Measured: From baseline (treatment) up to week 24.
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.
Measured: From baseline (treatment) up to week 24.
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.
Measured: From baseline (treatment) up to week 24.
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
Measured: From baseline (treatment) up to week 24
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.
Measured: From baseline (treatment) up to week 24
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.
Measured: From baseline (treatment) up to week 24
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.
Measured: From baseline (treatment) up to week 24
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.
Measured: From Day 1 up to week 24.
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.
Measured: Baseline (treatment) and 12 weeks after aflibercept injection
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
Measured: At 12 weeks after aflibercept injection
Number of Aflibercept Administrations
Total number of injections in both eyes.
Measured: From baseline (treatment) up to week 24.
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.
Measured: From baseline (treatment) up to week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start25 Sep 2019
- Primary completion12 Feb 2021
- Study completion12 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of Prematurity (ROP)Studies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004208
- Sponsor's protocol ID
- 20090
- Other IDs
- 2018-002611-99, 2018
- Acronym
- FIREFLEYE
- Status last verified
- May 2022
- First submitted
- 28 Jun 2019
- Last updated
- 6 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Stahl A, Azuma N, Wu WC, Lepore D, Sukgen E, Nakanishi H, Mazela J, Leal S, Pieper A, Schlief S, Eissing T, Turner KC, Zhao A, Winkler J, Hochel J, Kofuncu E, Zimmermann T; FIREFLEYE Study Group. Systemic exposure to aflibercept after intravitreal injection in premature neonates with retinopathy of prematurity: results from the FIREFLEYE randomized phase 3 study. Eye (Lond). 2024 Jun;38(8):1444-1453. doi: 10.1038/s41433-023-02919-9. Epub 2024 Jan 10.
PubMed 38200320Stahl 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.
PubMed 35881122
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04004208
- Acronym / sponsor ID
- FIREFLEYE / 20090
- Conditions
- Retinopathy of Prematurity (ROP)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 12 Feb 2021 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Posted 6 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aflibercept arm | Experimental | Drug: Eylea (Aflibercept, BAY86-5321)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. |
| Laser photocoagulation arm | Active comparator | Procedure: Laser photocoagulationSubjects randomized to laser photocoagulation will receive treatment in each eligible eye at baseline. Retreatments may be administered if needed. |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eylea (Aflibercept, BAY86-5321)Solution in a sterile glass vial, Dose A, IVT injection. | Drug | Aflibercept arm |
| Laser photocoagulationTranspupillary conventional laser ablative therapy | Procedure or surgery | Laser photocoagulation arm |
Primary outcome
Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes
Time frame: At 24 weeks after starting study treatment
Active ROP was defined as ROP requiring treatment. Unfavorable structural outcomes included retinal detachment, macular dragging, macular fold, or retrolental opacity.
12 secondary outcomes
Proportion of Participants Requiring Intervention With a Second Treatment Modality
Time frame: From baseline (treatment) up to week 24.
Proportion of Participants With Recurrence of ROP
Time frame: From baseline (treatment) up to week 24.
Exploration of ROP Activity Scale Proposed by the International Neonatal Consortium
Time frame: From baseline (treatment) up to week 24.
Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs)
Time frame: From baseline (treatment) up to week 24
Percentage of Participants With Ocular Serious Adverse Events (SAEs)
Time frame: From baseline (treatment) up to week 24
Percentage of Participants With Systemic TEAEs
Time frame: From baseline (treatment) up to week 24
Percentage of Participants With Systemic SAEs
Time frame: From baseline (treatment) up to week 24
Concentrations of Free Aflibercept in Plasma
Time frame: From Day 1 up to week 24.
Number of Participants With Anti-drug Antibodies (ADA)
Time frame: Baseline (treatment) and 12 weeks after aflibercept injection
Number of Participants With Potential Neutralizing Antibodies (NAb)
Time frame: At 12 weeks after aflibercept injection
Number of Aflibercept Administrations
Time frame: From baseline (treatment) up to week 24.
Number of Laser Treatments
Time frame: From baseline (treatment) up to week 24.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38200320Stahl A, Azuma N, Wu WC, Lepore D, Sukgen E, Nakanishi H, Mazela J, Leal S, Pieper A, Schlief S, Eissing T, Turner KC, Zhao A, Winkler J, Hochel J, Kofuncu E, Zimmermann T; FIREFLEYE Study Group. Systemic exposure to aflibercept after intravitreal injection in premature neonates with retinopathy of prematurity: results from the FIREFLEYE randomized phase 3 study. Eye (Lond). 2024 Jun;38(8):1444-1453. doi: 10.1038/s41433-023-02919-9. Epub 2024 Jan 10.
- Derived from this study: PubMed 35881122Stahl 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.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
90 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eylea (Aflibercept, BAY86-5321) and Laser photocoagulation in people with Retinopathy of Prematurity (ROP), run by Bayer at 90 sites in 27 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in Japan, Turkey (Türkiye), Russia, Bulgaria, Italy and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes (time frame: At 24 weeks after starting study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04004208, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.