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History of Changes for Study: NCT04101721
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity (BUTTERFLEYE)
Latest version (submitted September 21, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 23, 2019 None (earliest Version on record)
2 November 20, 2019 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 January 6, 2020 Contacts/Locations and Study Status
4 May 15, 2020 Contacts/Locations, IPDSharing and Study Status
5 June 4, 2020 Contacts/Locations and Study Status
6 July 7, 2020 Contacts/Locations and Study Status
7 August 31, 2020 Contacts/Locations, Study Status and Study Identification
8 December 26, 2020 Contacts/Locations and Study Status
9 February 3, 2021 Contacts/Locations and Study Status
10 May 21, 2021 Contacts/Locations and Study Status
11 October 12, 2021 Recruitment Status, Study Status, Contacts/Locations, Study Design and Eligibility
12 December 20, 2021 Contacts/Locations and Study Status
13 September 21, 2022 Recruitment Status and Study Status
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Study NCT04101721
Submitted Date:  September 23, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: VGFTe-ROP-1920
Brief Title: Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity (BUTTERFLEYE)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2019
Overall Status: Not yet recruiting
Study Start: October 30, 2019
Primary Completion: April 1, 2022 [Anticipated]
Study Completion: April 1, 2022 [Anticipated]
First Submitted: September 23, 2019
First Submitted that
Met QC Criteria:
September 23, 2019
First Posted: September 24, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
September 23, 2019
Last Update Posted: September 24, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Regeneron Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Retinopathy of Prematurity
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 112 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
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.

Open or close this module Contacts/Locations
Central Contact Person: Clinical Trials Administrator
Telephone: 844-734-6643
Email: clinicaltrials@regeneron.com
Study Officials: Clinical Trial Management
Study Director
Regeneron Pharmaceuticals
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Information:
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://errs.regeneron.com/external
Open or close this module References
Citations:
Links:
Available IPD/Information:

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