Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
84
Countries
2
Sites
3
Retinopathy of prematurity (ROP)
The primary objectives of the study are: • To evaluate binocular visual acuity at the end of this study in patients included from the VGFTe-ROP-1920 study, for treatment of ROP. • To evaluate long-term safety outcomes in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 22 Mar 2022 → ongoing
- Decision date (initial)
- 2024-10-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513231-24-00
- EudraCT number
- 2020-005875-10
- ClinicalTrials.gov
- NCT04515524
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
The primary objectives of the study are:
• To evaluate binocular visual acuity at the end of this study in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
• To evaluate long-term safety outcomes in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
Secondary objectives 2
- To describe visual function in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
- To describe overall development in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
Conditions and MedDRA coding
Retinopathy of prematurity (ROP)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10038933 | Retinopathy of prematurity | 100000004853 |
Regulatory references
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2019-001764-29 | 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, Randomizált, kontrollált, multicentrikus vizsgálat az intravitreális aflibercept hatásosságának, biztonságosságának és tolerálhatóságának lézer-fotokoagulációval szembeni értékelésére koraszülött retinopátiában szenvedő betegeknél , Estudio aleatorizado, controlado y multicéntrico para evaluar la eficacia, la seguridad y la tolerabilidad de aflibercept intravítreo comparado con la fotocoagulación con láser en pacientes con retinopatía del prematuro, Estudio aleatorizado, controlado y multicéntrico para evaluar la eficacia, la seguridad y la tolerabilidad de aflibercept intravítreo comparado con la fotocoagulación con láser en pacientes con retinopatía del prematuro, Estudio aleatorizado, controlado y multicéntrico para evaluar la eficacia, la seguridad y la tolerabilidad de aflibercept intravítreo comparado con la fotocoagulación con láser en pacientes con retinopatía del prematuro, Randomizované, kontrolované, multicentrické klinické skúšanie na vyhodnotenie účinnosti, bezpečnosti a znášanlivosti intravitreálne podaného afliberceptu v porovnaní s laserovou fotokoaguláciou u pacientov s retinopatiou nedonosených, Randomizované, kontrolované, multicentrické klinické skúšanie na vyhodnotenie účinnosti, bezpečnosti a znášanlivosti intravitreálne podaného afliberceptu v porovnaní s laserovou fotokoaguláciou u pacientov s retinopatiou nedonosených, Randomizované, kontrolované, multicentrické klinické skúšanie na vyhodnotenie účinnosti, bezpečnosti a znášanlivosti intravitreálne podaného afliberceptu v porovnaní s laserovou fotokoaguláciou u pacientov s retinopatiou nedonosených, Randomizovaná, kontrolovaná, multicentrická studie k posouzení účinnosti, bezpečnosti a snášenlivosti intravitreálně podávaného afliberceptu ve srovnání s laserovou fotokoagulací u pacientů s retinopatií nedonošených, Studio multicentrico, randomizzato, controllato per valutare l’efficacia, la sicurezza e la tollerabilità di aflibercept intravitreale rispetto alla fotocoagulazione laser in pazienti con retinopatia del prematuro |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patient was treated in study VGFTe-ROP-1920
- Age <13 months of chronological age
- Signed informed consent from parent(s)/legal guardian(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Exclusion criteria 1
- 1. Patient has a condition preventing participation in the study, or performance of study procedures. NOTE: Other Inclusion/Exclusion criteria may apply
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Binocular best-corrected visual acuity (BCVA)
- Proportion of Patients with Adverse Events
- Proportion of Patients with Serious Adverse Events
Secondary endpoints 8
- Proportion of patients developing unfavorable ocular structural outcome
- BCVA in each eye
- Refractive spherical equivalent in each eye
- Neurodevelopmental outcomes using BSID-III
- Neurodevelopmental outcomes using WPPSI-IV
- Neurodevelopmental outcomes using VABS-II
- Proportion of patients with recurrence of ROP
- Proportion of patients requiring treatment for ROP
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Eylea 40 mg/mL solution for injection in a vial
PRD3117103 · Product
- Active substance
- Aflibercept
- Substance synonyms
- BAY 86-5321, ABP 938, AVE0005, BAY86-5321, VEGF TRAP, BAY 86-5319
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 0 mg/ml milligram(s)/millilitre
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- S01LA05 — -
- Marketing authorisation
- EU/1/12/797/002
- MA holder
- BAYER AG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Regeneron Pharmaceuticals Inc.
- Sponsor organisation
- Regeneron Pharmaceuticals Inc.
- Address
- 777 Old Saw Mill River Road
- City
- Tarrytown
- Postcode
- 10591-6717
- Country
- United States
Scientific contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Clinical Trial Information
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 12, Code 5, Data management |
| Ercules Comunicazioni S.r.l. ORG-100047368
|
Chieri, Italy | Other |
| Iqvia Pharma Inc. ORG-100039063
|
Durham, United States | Data management, E-data capture |
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruitment ended | 5 | 2 |
| Romania | Ongoing, recruitment ended | 2 | 1 |
| Rest of world
Russian Federation, Vietnam, United States, Korea, Republic of, Colombia, Turkey, Taiwan, Thailand
|
— | 77 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2022-03-22 | 2022-03-22 | 2022-05-23 | ||
| Romania | 2022-08-11 | 2022-08-11 | 2022-08-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513231-24-00 Redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank document | 1.0 |
| Recruitment arrangements (for publication) | K1_VGFTe-ROP-2036 Recruitment and Informed consent procedure description Bulgarian_redaction Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_VGFTe-ROP-2036_SIS-ICF_Main_BG | 1.0 |
| Subject information and informed consent form (for publication) | L1_VGFTe-ROP-2036_SIS-ICF_Main_RO | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC AFLIBERCEPT | II/0090 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-14 | Romania | Acceptable with conditions 2024-10-01
|
2024-10-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-30 | Romania | Acceptable 2025-01-08
|
2025-01-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-09 | Romania | Acceptable 2025-07-02
|
2025-07-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-19 | Romania | Acceptable 2025-11-03
|
2025-11-07 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-13 | Acceptable | 2026-04-16 |