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

NCT04101721 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: VGFTe-ROP-19202019-001764-29
• Study Type: interventional
• Target: 127
• Locations: 13 countries
• Sites: 52

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.

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age

  Active ROP was ROP requiring treatment and unfavorable structural outcome was defined as retinal detachment, macular dragging, macular fold, or retrolental opacity. For participants with both eyes enrolled in the study, both eyes must have met the endpoint. Participants with only one study eye enrolled were responders if the respective eye responded.

  Baseline to week 52 of chronological age

Secondary Outcomes (4)

• Percentage of Participants Requiring Intervention With a Second Treatment Modality From Baseline to Week 52 of Chronological Age

  Baseline to to week 52 of chronological age

• Percentage of Participants With Recurrence of ROP Through Week 52 of Chronological Age

  Baseline to week 52 of chronological age

• Percentage of Participants With Ocular Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

  Baseline to Week 52 of chronological age

• Percentage of Participants With Systematic (Non-ocular) TEAEs and TESAEs

  Baseline to Week 52 of chronological age

Study Arms (2)

Aflibercept Group

EXPERIMENTAL

Patients will receive a single intravitreal (IVT) injection per eligible eye at baseline.

Drug: aflibercept

Laser Group

EXPERIMENTAL

Patients will undergo laser treatment in each eligible eye at baseline.

Procedure: laser photocoagulation

Interventions

aflibercept DRUG

Administered IVT

Also known as: EYLEA®, REGN3, VEGF trap-eye, BAY86-5321

Aflibercept Group

laser photocoagulation PROCEDURE

Transpupillary conventional laser will be administered according to standard local procedures.

Laser Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (52)

Regeneron Study Site

Phoenix, Arizona, 85016, United States

Location

Regeneron Study Site

La Jolla, California, 92093, United States

Location

Regeneron Study Site

Loma Linda, California, 92354, United States

Location

Regeneron Study Site

Orange, California, 92868, United States

Location

Regeneron Study Site

Palo Alto, California, 94303, United States

Location

Regeneron Study Site

San Diego, California, 92123, United States

Location

Regeneron Study Site

San Francisco, California, 94143, United States

Location

Regeneron Study Site

Gainesville, Florida, 32608, United States

Location

Regeneron Study Site

Augusta, Georgia, 78705, United States

Location

Regeneron Study Site

Chicago, Illinois, 60612, United States

Location

Regeneron Study Site

Boston, Massachusetts, 02111, United States

Location

Regeneron Study Site

Ann Arbor, Michigan, 48105, United States

Location

Regeneron Study Site

Royal Oak, Michigan, 48073, United States

Location

Regeneron Study Site

Brooklyn, New York, 11203, United States

Location

Regeneron Study Site

Brooklyn, New York, 11213, United States

Location

Regeneron Study Site

Buffalo, New York, 14209, United States

Location

Regeneron Study Site

New York, New York, 10017, United States

Location

Regeneron Study Site

New York, New York, 10029, United States

Location

Regeneron Study Site

The Bronx, New York, 10462, United States

Location

Regeneron Study Site

Valhalla, New York, 10595, United States

Location

Regeneron Study Site

Cleveland, Ohio, 44106, United States

Location

Regeneron Study Site

Oklahoma City, Oklahoma, 73104, United States

Location

Regeneron Study Site

Providence, Rhode Island, 02905, United States

Location

Regeneron Study Site

Austin, Texas, 78705, United States

Location

Regeneron Study Site

San Antonio, Texas, 78229, United States

Location

Regeneron Study Site

San Antonio, Texas, 78240, United States

Location

Regeneron Study Site

Morgantown, West Virginia, 26506, United States

Location

Regeneron Study Site

Sofia, 1407, Bulgaria

Location

Regeneron Study Site

Sofia, 1504, Bulgaria

Location

Regeneron Study Site

Varna, 9002, Bulgaria

Location

Regeneron Study Site

Medellín, Antioquia, 50034, Colombia

Location

Regeneron Study Site

Floridablanca, Santander Department, 681004, Colombia

Location

Regeneron Study Site

Ostrava-Poruba, 708 52, Czechia

Location

Regeneron Study Site

Debrecen, H-4032, Hungary

Location

Regeneron Study Site

Iași, 700038, Romania

Location

Regeneron Study Site

Saint Petersburg, Sankt-Peterburg, 194100, Russia

Location

Regeneron Study Site

Moscow, 119571, Russia

Location

Regeneron Study Site

Moscow, 119620, Russia

Location

Regeneron Study Site

Bratislava, 833 40, Slovakia

Location

Regeneron Study Site

Cheonan, 31151, South Korea

Location

Regeneron Study Site

Kaohsiung City, 81346, Taiwan

Location

Regeneron Study Site

Pathum Wan, Bangkok, 10330, Thailand

Location

Regeneron Study Site

Ratchathewi, Bangkok, 10400, Thailand

Location

Regeneron Study Site

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Regeneron Study Site

Chiang Mai, Chiang Mai, 50200, Thailand

Location

Regeneron Study Site

Khon Kaen, 40002, Thailand

Location

Regeneron Study Site

Adana, 4522, Turkey (Türkiye)

Location

Regeneron Study Site

Ankara, 06100, Turkey (Türkiye)

Location

Regeneron Study Site

Ankara, 06560, Turkey (Türkiye)

Location

Regeneron Study Site

Eskişehir, 26480, Turkey (Türkiye)

Location

Regeneron Study Site

Ho Chi Minh City, 70000, Vietnam

Location

Regeneron Study Site

Huế, 100000, Vietnam

Location

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 24, 2019
• Study Start: October 30, 2019
• Primary Completion: August 18, 2022
• Study Completion: August 18, 2022
• Last Updated: July 20, 2023
• Results First Posted: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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).

Locations

CZ (1); US (27); RU (3); VN (2); TH (5); HU (1); CO (2); TW (1); BU (3); SL (1); RO (1); TU (4); KR (1)