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Trial record 1 of 1 for:    RANDOMIZED, CONTROLLED, MULTI-CENTER STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF INTRAVITREAL AFLIBERCEPT COMPARED TO LASER PHOTOCOAGULATION IN PATIENTS WITH RETINOPATHY OF PREMATURITY
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Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity (BUTTERFLEYE)

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ClinicalTrials.gov Identifier: NCT04101721
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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Brief Summary:
The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Drug: aflibercept Procedure: laser photocoagulation Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open-Label
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Aflibercept Group
Patients will receive a single intravitreal (IVT) injection per eligible eye at baseline.
 Drug: aflibercept
Administered IVT
Other Names:
  • EYLEA®
  • REGN3
  • VEGF trap-eye
  • BAY86-5321
Experimental: Laser Group
Patients will undergo laser treatment in each eligible eye at baseline.
 Procedure: laser photocoagulation
Transpupillary conventional laser will be administered according to standard local procedures.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with absence of active retinopathy of prematurity (ROP) and of unfavorable structural outcomes [ Time Frame: At Week 52 of chronological age ]
    For patients with both eyes enrolled in the study, both eyes must meet the endpoint.


Secondary Outcome Measures :
  1. Proportion of patients requiring intervention with a second treatment modality [ Time Frame: Baseline to Week 52 of chronological age ]
  2. Proportion of patients with recurrence of ROP [ Time Frame: Through Week 52 of chronological age ]
  3. Proportion of patients with ocular treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: Baseline to Week 52 of chronological age ]
  4. Proportion of patients with systematic TEAEs and SAEs [ Time Frame: Baseline to Week 52 of chronological age ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

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

  • Patients with treatment-naïve retinopathy of prematurity (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)

Key Exclusion Criteria:

  • Known or suspected chromosomal abnormality, genetic disorder, or syndrome
  • Previous exposure to any Intravitreal (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 neonatal intensive care unit 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 stage 4 and stage 5)
  • ROP involving only Zone III

NOTE: Other protocol defined inclusion/exclusion criteria apply.

Contacts and Locations
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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): NCT04101721


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04101721    
Other Study ID Numbers: VGFTe-ROP-1920
2019-001764-29 ( EudraCT Number )
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
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