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出境医 / 临床实验 / Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy (FIREFLEYE)

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

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.

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity (ROP) Drug: Eylea (Aflibercept, BAY86-5321) Procedure: Laser photocoagulation Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 25, 2019
Actual Primary Completion Date : February 12, 2021
Actual Study Completion Date : February 12, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Aflibercept arm
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.
 Drug: Eylea (Aflibercept, BAY86-5321)
Solution in a sterile glass vial, Dose A, IVT injection.
Active Comparator: Laser photocoagulation arm
Subjects randomized to laser photocoagulation will receive treatment in each eligible eye at baseline. Retreatments may be administered if needed.
 Procedure: Laser photocoagulation
Transpupillary conventional laser ablative therapy
Outcome Measures
Primary Outcome Measures :
  1. Proportion of patients with absence of active ROP and unfavorable structural outcomes [ Time Frame: At 24 weeks after starting study treatment ]

Secondary Outcome Measures :
  1. Number of requirement for intervention with a second treatment modality [ Time Frame: From baseline to Week 24 ]
  2. Recurrence of ROP [ Time Frame: From baseline to Week 24 ]
  3. To explore new Retinopathy of Prematurity Activity Scale proposed by the International Neonatal Consortium [ Time Frame: From baseline to Week 24 ]
  4. Number of aflibercept administrations [ Time Frame: From baseline to Week 24 ]
  5. Number of laser treatments [ Time Frame: From baseline to Week 24 ]
  6. Proportion of participants with ocular TEAEs and SAEs [ Time Frame: From baseline to Week 24 ]
    TEAE: treatment-emergent adverse event SAE: serious adverse event

  7. Proportion of participants with systemic TEAEs and SAEs [ Time Frame: From baseline to Week 24 ]
  8. Systemic exposure to free aflibercept (at expected maximum plasma concentration and during elimination period from plasma) determined by sparse sampling [ Time Frame: From baseline to Week 24 ]
  9. Presence of anti-drug antibodies [ Time Frame: Before and 12 weeks after aflibercept injection ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Show Show 63 study locations
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE September 25, 2019
Actual Primary Completion Date February 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019) 		Proportion of patients with absence of active ROP and unfavorable structural outcomes [ Time Frame: At 24 weeks after starting study treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2020)
  • Number of requirement for intervention with a second treatment modality [ Time Frame: From baseline to Week 24 ]
  • Recurrence of ROP [ Time Frame: From baseline to Week 24 ]
  • To explore new Retinopathy of Prematurity Activity Scale proposed by the International Neonatal Consortium [ Time Frame: From baseline to Week 24 ]
  • Number of aflibercept administrations [ Time Frame: From baseline to Week 24 ]
  • Number of laser treatments [ Time Frame: From baseline to Week 24 ]
  • Proportion of participants with ocular TEAEs and SAEs [ Time Frame: From baseline to Week 24 ]
    TEAE: treatment-emergent adverse event SAE: serious adverse event
  • Proportion of participants with systemic TEAEs and SAEs [ Time Frame: From baseline to Week 24 ]
  • Systemic exposure to free aflibercept (at expected maximum plasma concentration and during elimination period from plasma) determined by sparse sampling [ Time Frame: From baseline to Week 24 ]
  • Presence of anti-drug antibodies [ Time Frame: Before and 12 weeks after aflibercept injection ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Number of requirement for intervention with a second treatment modality [ Time Frame: From baseline to Week 24 ]
  • Recurrence of ROP [ Time Frame: From baseline to Week 24 ]
  • To explore new Retinopathy of Prematurity Activity Scale proposed by the International Neonatal Consortium [ Time Frame: From baseline to Week 24 ]
  • Number of aflibercept administrations [ Time Frame: From baseline to Week 24 ]
  • Number of laser treatments [ Time Frame: From baseline to Week 24 ]
  • Proportion of participants with ocular TEAEs and SAEs [ Time Frame: From baseline to Week 24 ]
    TEAE: treatment-emergent adverse event SAE: serious adverse event
  • Proportion of participants with systemic TEAEs and SAEs [ Time Frame: From baseline to Week 24 ]
  • Systemic exposure to free aflibercept (at expected maximum plasma concentration and during elimination period from plasma) determined by sparse sampling [ Time Frame: From baseline to Week 4 ]
  • Presence of anti-drug antibodies [ Time Frame: Before and 12 weeks after aflibercept injection ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Retinopathy of Prematurity (ROP)
Intervention  ICMJE
  • Drug: Eylea (Aflibercept, BAY86-5321)
    Solution in a sterile glass vial, Dose A, IVT injection.
  • Procedure: Laser photocoagulation
    Transpupillary conventional laser ablative therapy
Study Arms  ICMJE
  • Experimental: Aflibercept arm
    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.
    Intervention: Drug: Eylea (Aflibercept, BAY86-5321)
  • Active Comparator: Laser photocoagulation arm
    Subjects randomized to laser photocoagulation will receive treatment in each eligible eye at baseline. Retreatments may be administered if needed.
    Intervention: Procedure: Laser photocoagulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2019) 		113
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 12, 2021
Actual Primary Completion Date February 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 32 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   Brazil,   Bulgaria,   Czechia,   Greece,   Hong Kong,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom
Removed Location Countries Canada,   Estonia,   France,   Germany,   Latvia,   Lithuania,   Switzerland
 
Administrative Information
NCT Number  ICMJE NCT04004208
Other Study ID Numbers  ICMJE 20090
2018-002611-99 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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.
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Regeneron Pharmaceuticals
Investigators  ICMJE Not Provided
PRS Account Bayer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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