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BUTTERFLEYE: Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04101721
Collaborator
(none)
127
Enrollment
52
Locations
2
Arms
34.5
Anticipated Duration (Months)
2.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
127 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 :
Oct 30, 2019
Anticipated Primary Completion Date :
Sep 15, 2022
Anticipated Study Completion Date :
Sep 15, 2022

Arms and Interventions

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

    Primary Outcome Measures

    1. Proportion of patients with absence of active retinopathy of prematurity (ROP) and of unfavorable structural outcomes [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 [Baseline to Week 52 of chronological age]

    2. Proportion of patients with recurrence of ROP [Through Week 52 of chronological age]

    3. Proportion of patients with ocular treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [Baseline to Week 52 of chronological age]

    4. Proportion of patients with systematic TEAEs and SAEs [Baseline to Week 52 of chronological age]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Regeneron Study Site Phoenix Arizona United States 85016
    2 Regeneron Study Site La Jolla California United States 92093
    3 Regeneron Study Site Loma Linda California United States 92354
    4 Regeneron Study Site Orange California United States 92868
    5 Regeneron Study Site Palo Alto California United States 94303
    6 Regeneron Study Site San Diego California United States 92123
    7 Regeneron Study Site San Francisco California United States 94143
    8 Regeneron Study Site Gainesville Florida United States 32608
    9 Regeneron Study Site Augusta Georgia United States 78705
    10 Regeneron Study Site Chicago Illinois United States 60612
    11 Regeneron Study Site Boston Massachusetts United States 02111
    12 Regeneron Study Site Ann Arbor Michigan United States 48105
    13 Regeneron Study Site Royal Oak Michigan United States 48073
    14 Regeneron Study Site Bronx New York United States 10462
    15 Regeneron Study Site Brooklyn New York United States 11203
    16 Regeneron Study Site Brooklyn New York United States 11213
    17 Regeneron Study Site Buffalo New York United States 14209
    18 Regeneron Study Site New York New York United States 10017
    19 Regeneron Study Site New York New York United States 10029
    20 Regeneron Study Site Valhalla New York United States 10595
    21 Regeneron Study Site Cleveland Ohio United States 44106
    22 Regeneron Study Site Oklahoma City Oklahoma United States 73104
    23 Regeneron Study Site Providence Rhode Island United States 02905
    24 Regeneron Study Site Austin Texas United States 78705
    25 Regeneron Study Site San Antonio Texas United States 78229
    26 Regeneron Study Site San Antonio Texas United States 78240
    27 Regeneron Study Site Morgantown West Virginia United States 26506
    28 Regeneron Study Site Sofia Bulgaria 1407
    29 Regeneron Study Site Sofia Bulgaria 1504
    30 Regeneron Study Site Varna Bulgaria 9002
    31 Regeneron Study Site Medellin Antioquia Colombia 50034
    32 Regeneron Study Site Floridablanca Santander Colombia 681004
    33 Regeneron Study Site Ostrava-Poruba Czechia 708 52
    34 Regeneron Study Site Debrecen Hungary H-4032
    35 Regeneron Study Site Cheonan Korea, Republic of 31151
    36 Regeneron Study Site Iași Romania 700038
    37 Regeneron Study Site Saint-Petersburg Sankt-Peterburg Russian Federation 194100
    38 Regeneron Study Site Moscow Russian Federation 119571
    39 Regeneron Study Site Moscow Russian Federation 119620
    40 Regeneron Study Site Bratislava Slovakia 833 40
    41 Regeneron Study Site Kaohsiung Taiwan 81346
    42 Regeneron Study Site Pathum Wan Bangkok Thailand 10330
    43 Regeneron Study Site Ratchathewi Bangkok Thailand 10400
    44 Regeneron Study Site Chiangmai Chiang Mai Thailand 50200
    45 Regeneron Study Site Hat Yai Songkhla Thailand 90110
    46 Regeneron Study Site Khon Kaen Thailand 40002
    47 Regeneron Study Site Adana Turkey 4522
    48 Regeneron Study Site Ankara Turkey 06100
    49 Regeneron Study Site Ankara Turkey 06560
    50 Regeneron Study Site Eskisehir Turkey 26480
    51 Regeneron Study Site Ho Chi Minh Vietnam 70000
    52 Regeneron Study Site Hue Vietnam 100000

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04101721
    Other Study ID Numbers:
    • VGFTe-ROP-1920
    • 2019-001764-29
    First Posted:
    Sep 24, 2019
    Last Update Posted:
    Dec 21, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Retinal Diseases
    Retinopathy of Prematurity
    Premature Birth
    Aflibercept

    Study Results

    No Results Posted as of Dec 21, 2021