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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004208
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine


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




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 4 ]
  9. Presence of anti-drug antibodies [ Time Frame: Before and 12 weeks after aflibercept injection ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004208


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04004208    
Other Study ID Numbers: 20090
2018-002611-99 ( EudraCT Number )
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Diseases
Retinopathy of Prematurity
Premature Birth
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases