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Age Related Macular DegenerationPhase 3NCT04740671

A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD

A Phase 3 study testing HLX04-O and ranibizumab in people with Age Related Macular Degeneration, run by Shanghai Henlius Biotech at 126 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will compare the efficacy and safety of HLX04-O administered by intravitreal injection (IVT) with ranibizumab in patients with active wAMD. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age Related Macular Degeneration
What is being tested?
HLX04-O and ranibizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
410 participants
Where
126 sitesin 15 countries
Study dates
1 Jul 2021to 31 Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable to understand and sign the informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Women or men aged ≥50 years when signing the ICF.
  • In the Investigator's judgment, willing and able to complete all visits and assessments adhering to the prohibitions and restrictions specified in this protocol.
  • Newly diagnosed, untreated, active CNV lesions secondary to age-related macular degeneration that affect the central subfield (CSF) in the study eye. Active CNV was defined as leakage on fluorescein angiography (FA) and subretinal or intraretinal fluid on optical coherence tomography (OCT) with confirmation of the reading center during screening.
  • The total lesion area (including hemorrhage, scar and neovascularization) of the study eye ≤12 disc area (DA) with confirmation of the reading center before randomization
  • The BCVA letters between 24 and 73, inclusive, in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
  • Participants' fellow (non-study) eye must have a BCVA of 24 letters or better.
  • Clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm the diagnosis.

Who cannot join

  • Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis or atrophy involving the fovea, or CNV due to other causes in the study eye (e.g., ocular histoplasmosis, trauma,pathological myopia, etc.) with confirmation of the reading center.
  • The fellow (non-study) eye needs anti-VEGF IVT injection (e.g. CNV due to wAMD, trauma, pathological myopia, retina vein occlusion, diabetic macular edema, etc.) in the next 3 months after randomization, in the investigator's judgment.
  • Aphakia (except intraocular lens) or posterior capsular rupture of the lens (except yttrium-aluminium-garnet (YAG) laser posterior capsulotomy after intraocular lens implantation ≥30 days prior to first dose) in the study eye.
  • Active or recent (within 1 month prior to dose 1) intraocular, extraocular or periocular infection (including conjunctivitis, keratitis, scleritis or endophthalmitis), or history of idiopathic or autoimmune-associated uveitis in either eye.
  • Vitreous hemorrhage in the study eye within 3 months prior to dose 1.
  • Corneal dystrophy or history of corneal transplantation, scleral softening or history of scleral softening, history of rhegmatogenous retinal detachment or macular hole (Stage II, III or IV) in the study eye.
Show all 29Show fewer
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure [IOP] ≥25 mmHg despite treatment with antiglaucoma medication), and/or glaucoma filtering surgery (e.g., trabeculectomy, scleral nipping, non-penetrating trabeculectomy, etc.)
  • Equivalent spherical diopter of the study eye ≥-8D. For participants who had undergone refractive correction or cataract surgery, the equivalent spherical diopter of the study eye before surgery ≥-8D.
  • Estimated by the Investigator, any concurrent intraocular condition except wAMD (e.g., diabetic retinopathy, dry AMD, retina vein occlusion, uveitis, angioid streaks, retinal detachment, epiretinal membrane, amblyopia, central serous chorioretinopathy, etc.) in the study eye that limited the potential to gain visual acuity upon treatment with the investigational product, or could have required medical or surgical intervention during the study to prevent or treat visual loss.
  • Underwent intraocular surgery including verteporfin photodynamic therapy (PDT), transpupillary thermotherapy, macular translocation, vitrectomy, laser photocoagulation in macular area, other surgery in macular area or surgery to treat AMD.
  • Previous extraocular or periocular surgery within 1 month or intraocular surgery (except the surgery mentioned in exclusion 10 ,such as cataract surgery, etc.) within 3 months prior to dose 1, or current unhealed wound, moderate or severe ulcer or fracture in the study eye.
  • Subconjunctival or intraocular use of corticosteroids within 3 months (including subconjunctival or intraocular long-acting implant within 6 months) prior to dose 1 in the study eye. Use of systemic corticosteroids for 30 or more consecutive days within 3 months prior to dose 1. Inhaled, nasal or dermal steroids are permitted. Topical ocular corticosteroids administered for 30 or more consecutive days in the study eye within 3 months prior to dose 1.
  • Previous systemic anti-VEGF therapy or IVT injection of any anti-VEGF drug into either eye or other ocular use of anti-VEGF drug within 3 months prior to dose 1.
  • Participated in any drug (other than vitamins and minerals) or device clinical trials 3 months or the duration of 5 half-lives of the study drug (which is longer) before the first dose and have used the test drug or received device treatment.
  • Pregnancy or lactation, or fertile men or women not willing to use effective contraception from the day when ICF was signed to at least 6 months following the last dose of study intervention.
  • Infertile women or men fail to meet either of the following ones: 1) menopause (≥12 continuous months of amenorrhea with no identified cause other than menopause before screening); 2) surgically sterilized.
  • Fertile women or men fail to meet either of the following ones: 1) women of childbearing potential must have a negative urine or serum pregnancy test result within 14 days prior to initiation of the study intervention, and should not breastfeed. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test; 2) agreement to remain abstinent (refrain from heterosexual intercourse) or use effective contraceptive methods from signed ICF to at least 6 months following the last dose of study intervention. Effective contraceptive methods with a failure rate of <1% per year, including bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices (IUDs), and copper IUDs.
  • In the Investigator's judgment, there is evidence of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the participant at high risk for treatment complications (e.g. stroke or myocardial infarction within 6 months prior to dose 1, uncontrolled hypertension (systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥100 mmHg), etc.).
  • Uncontrolled diabetes (defined as HbA1c>10.0%).
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) is more than twice the upper limit of normal (ULN), and/or serum creatinine is 1.2 times more than the ULN, and is clinically significant in the opinion of the Investigator.
  • Abnormal coagulation function: prothrombin time(PT) or International normalized ratio (INR) ≥ 1.5 ×ULN, or activated partial thromboplastin time (aPTT) ≥1.5 ×ULN, and is clinically significant in the opinion of the Investigator.
  • Active disseminated intravascular coagulation and obvious bleeding tendency within 3 months prior to dose 1.
  • Evidence of significant uncontrolled concomitant diseases such as cardiovascular diseases, nervous system diseases, respiratory system diseases, urinary system diseases, digestive system diseases and endocrine diseases (e.g., stroke, myocardial infarction).
  • Current treatment for active systemic infection, or history of recurrent serious infections.
  • Known active or suspected autoimmune diseases, requiring systemic immunosuppressive therapy.
  • Positive for syphilis screening test human immunodeficiency virus (HIV) infection or positive for HIV screening test.
  • Known allergy to any component of the study intervention or history of allergy to fluorescein or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study.
  • In the Investigator's judgment, other conditions considered not amenable to this study.
  • Participant who has been diagnosed to be COVID-19 within 2weeks prior to the first dose, or still symptomatic from an earlier infection (except symptoms associated with "Long COVID "), or displaying symptoms consistent with COVID-19 in the absence of a confirmed Covid-19 infection.

Trial locations and contacts

126 sites in 15 countries.

126 sites in 15 countries

United States42 sites

  • Piedmont Retina Specialists

    Asheville, North Carolina, 27103

  • Western Carolina Retinal Associates

    Asheville, North Carolina, 28803

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Retina Consultants of Charleston - Beaufort

    Beaufort, South Carolina, 29902

  • Retina Consultants of TEXAS- Newcastle

    Bellaire, Texas, 77401

  • Retina Consultants of Charleston: Charleston Neuroscience Institute

    Charleston, South Carolina, 29414

  • The University of Chicago, IL

    Chicago, Illinois, 60637

  • The University of Chicago

    Chicago, Illinois, 60637

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909

  • Retina Consultants of Minnesota

    Edina, Minnesota, 55435

  • Verum Research, LLC

    Eugene, Oregon, 97401

  • Emerson Clinical Research Institute

    Falls Church, Virginia, 22042

  • Carolina Center for Sight

    Florence, South Carolina, 29501

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Associated Retina Consultants-Gilbert

    Gilbert, Arizona, 85297

  • Global Research Management

    Glendale, California, 91204

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Graystone Eye

    Hickory, North Carolina, 28602

  • Mt. Olympus Research-Garcia

    Houston, Texas, 77015

  • Mt. Olympus Research/Museum Eye District

    Houston, Texas, 77015

  • Atlantis Eyecare, VMR Institute

    Huntington Beach, California, 92647

  • VMR Institute

    Huntington Beach, California, 92647

  • Mississippi Retina Associates

    Jackson, Mississippi, 39202

  • Florida Retina Institute-Orlando

    Jacksonville, Florida, 32216

  • Retina Associates LLC

    Lenexa, Kansas, 66215

  • South Coast Retina Center

    Long Beach, California, 90807

  • Retina Consultants of Orange County

    Los Alamitos, California, 90720

  • MACRO Trials/ Lazar Retina

    Los Angeles, California, 90048

  • Butchertown Clinical Trials

    Louisville, Kentucky, 40206

  • Retina Consultants of Nashville

    Nashville, Tennessee, 37203

  • Illinois Retina Associates

    Oak Park, Illinois, 60304

  • Florida Retina Institute-Orlando

    Orlando, Florida, 32806

  • Associated Retina Consultants-Phoenix

    Phoenix, Arizona, 85020

  • Retina Consultants of TEXAS - Round Rock

    Round Rock, Texas, 78681

  • VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota

    Saint Louis Park, Minnesota, 55416

  • Retina Associates of Utah, PLLC

    Salt Lake City, Utah, 84107

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah, 84107

  • University of South Florida

    Tampa, Florida, 33612

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

  • East West Eye Institute

    Torrance, California, 90505

  • North Carolina Retina Associates

    Wake Forest, North Carolina, 27332

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

Spain20 sites

  • VISSUM

    Alicante

  • Centro de Oftalmologia Barraquer

    Barcelona

  • Hospital Universitari Vall D Hebron

    Barcelona

  • Institito de Microcirugia Ocular

    Barcelona

  • Institut Catala de La Retina

    Barcelona

  • Oftalvist Clinic

    Burjassot

  • Hospital La Arruzafa

    Córdoba

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid

  • Hospital Universitario Puerta de Hierro

    Majadahonda

  • Instituto Oftalmologico Fernandez-Vega

    Oviedo

  • Clinica Universitario de Navarra

    Pamplona

  • Hospital Universitario Donostia

    San Sebastián

  • Omiq Hospital General de Catalunya

    Sant Cugat del Vallès

  • Hospital Universitario Virgen Macarena

    Seville

  • Clinica Oftalmologica Aiken

    Valencia

  • Consorcio Hospital General Universitario de Valencia

    Valencia

  • Fisabio Oftalmologia Medica

    Valencia

  • Hospital Rio Hortega

    Valladolid

  • Hospital Universitario Miguel Servet

    Zaragoza

Other trials in Spain

Poland12 sites

  • Nzoz E-Vita

    Bialystok, Podlaskie Voivodeship

  • Oftalmika Sp Z.O.O

    Bydgoszcz

  • Centrum Klinicke Oftalmologie S.R.O

    Katowice

  • Centrum Medyczne Promed

    Krakow, WA

  • Szpital SW. Rozy

    Krakow

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lubline

    Lublin

  • Szpital SW Wojciecha

    Poznan

  • Centrum Medyczne Uno-Med

    Tarnów

  • Caminomed Wojciech Jedrzejewski

    Tarnowskie Góry

  • Centrum Medyczne Piasta 47

    Wałbrzych

  • Nzoz Optimed

    Warsaw

  • Retina Okulistyka Sp.Z O.O.Sp.K.

    Warsaw

Other trials in Poland

Bulgaria10 sites

  • Specialized Eye Hospital For Active Treatment - Burgas Ltd

    Burgas

  • Vizus Eood

    Gorna Oryahovitsa, Veliko Tarnovo

  • Mhat Dr. Stamen Iliev Ad

    Montana, Montana

  • Assoc. Prof. Dr. Desislava Koleva Aipsmaed Sveti Luka Eood

    Plovdiv, Plovdiv

  • Medical Center Dar Plovdiv Ltd

    Plovdiv

  • Dcc Aleksandrovska Eood

    Sofia, Sofia

  • Umhat Lozenets Ead

    Sofia, Sofia

  • University First Mhat - Sofia Sv. Joan Krastitel Ead

    Sofia, Sofia

  • Medical Center Vereya Ltd

    Stara Zagora

  • Specialized Hospital For Active Treatment in Ophthalmology - Varna

    Varna, Varna

Other trials in Bulgaria

China8 sites

  • First Hospital of Jilin University

    Changchun, Jilin

  • Lanzhou University Second Hospital

    Lanzhou, Gansu

  • Shanghai First Peoples's Hospital

    Shanghai, Shanghai Municipality

  • Joint Shangtou International Eye Center Of Shantou University And The Chinese University Of Hong Kong

    Shantou, Guangdong

  • Shanxi Eye Hospital

    Taiyuan, Shanxi

  • Weifang Eye Hospital

    Weifang, Shandong

  • The Third Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

  • The People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia

Other trials in China

Slovakia7 sites

  • Ocna Klinika Szu F.D.R.Banska Bystrica

    Banská Bystrica

  • Fakultna Nemocnica Nitra

    Nitra

  • Fakultna Nemocnica S Poliklinikou Nove Zamky Oftalmologicke Nelozkove Oddelenie

    Nové Zámky

  • Nemocnica Poprad As Oftalmologicke Oddelenie Jzs

    Poprad

  • Nemocnica S Poliklinikou Trebisov A.S. Ocne Oddelenie Jzs

    Trebišov

  • Fakultna Nemocnica Trencin

    Trenčianske Teplice

  • Fakultna Nemocnica S Poliklinikou Zilina

    Žilina

Other trials in Slovakia

Germany6 sites

  • Ukb University of Bonn

    Bonn

  • University Hospital Freiburg

    Freiburg im Breisgau

  • Justus Liebig University Giessen

    Giessen

  • Johannes Gutenberg University Mainz

    Mainz

  • St Franziskus Hospital Munster

    Münster

  • Eye Clinic Sulzbach

    Sulzbach

Other trials in Germany

Hungary6 sites

  • Bajcsy-Zsilinszky Korhaz Es Rendelointezet

    Budapest, Budapest

  • Semmelweis Egyetem

    Budapest

  • Markhot Ferenc Oktatokorhaz Es Rendelointezet

    Eger

  • Ganglion Orvosi Kozpont

    Pécs

  • Pecsi Tudomanyegyetem Klinikai Kozpont - Szemeszeti Klinika

    Pécs

  • Szegedi Tudomanyegyetem Aok Szakk

    Szeged

Other trials in Hungary

Italy4 sites

  • Clinica Oculistica Ospedale Luigi Sacco, Universita' Degli Studi Di Milano

    Milan

  • Clinica Oculistica Universita Vita Salute - Irccs Ospedale San Raffaele

    Milan

  • Irccs Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia Onlus Rome, Italy

    Rome, Rome

  • Fondazione Policlinico Universitario Agostino Gemelli - Irccs Uoc Oculistica

    Rome

Other trials in Italy

Australia3 sites

  • The Alfred Hospital

    Melbourne

  • Lions Eye Institute

    Nedlands, Western Australia, WA 6009

  • Lions Eye Institute

    Nedlands

Other trials in Australia

France2 sites

  • Centre Hospitalier Universitaire Amiens-Picardie Service D'Ophthalmologie Amiens France

    Amiens

  • University Eye Clinic Centre Hospitalier Creteil Paris France

    Paris

Other trials in France

Latvia2 sites

  • P Stradina Clinical University Hospital

    Riga

  • Riga East University Hospital

    Riga

Other trials in Latvia

Serbia2 sites

  • Special Optalmological Hospital Belgrade

    Belgrade

  • Zvezdara University Medical Center

    Belgrade

Other trials in Serbia

Czechia1 site

  • Oftex Ocni Klinika

    Pardubice

Other trials in Czechia

Singapore1 site

  • National University Hospital

    Singapore

Other trials in Singapore

About this study

Official title: A Phase 3, Randomized, Double-masked, Active Controlled Study to Compare the Efficacy and Safety of HLX04-O Administered by Intravitreal Injection with Ranibizumab in Subjects with Wet Age-related Macular Degeneration (wAMD)

This study will compare the efficacy and safety of HLX04-O administered by intravitreal injection (IVT) with ranibizumab in patients with active wAMD.

Read the detailed description

This is a Phase 3, Randomized, Double-masked, Active Controlled Study to Compare the Efficacy and Safety of HLX04-O Administered by Intravitreal Injection with Ranibizumab in Subjects with wet Age-related Macular Degeneration (wAMD). This study will be conducted in approximately 90 sites in different countries or regions.

Being tested
HLX04-O, ranibizumab
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX04-ODrug

    Biologic recombinant anti-VEGF humanized monoclonal antibody, developed by Shanghai Henlius Biotech, Inc.

  • ranibizumabDrug

    Biologic anti-VEGF recombinant humanized monoclonal antibody fragment

Study groups in NCT04740671
Study groupRoleWhat they receive
HLX04-OExperimentalBiologic recombinant anti-VEGF humanized monoclonal antibody
Receives: Drug: HLX04-O
RanibizumabActive comparatorBiologic anti-VEGF recombinant humanized monoclonal antibody fragment
Receives: Drug: ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from baseline in BCVA at at Week 36

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: up to at Week 36

Secondary outcomes (8)

  1. Key Secondary Outcome : Mean change from baseline in BCVA at Week 48.

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: up to Week 48

  2. Mean change in BCVA over time

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: up to Week 48

  3. Proportion of patients gaining at least 15 letters in the BCVA at Week 12, 24, 36 and 48

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: up to Week 12, 24, 36 and 48

  4. Proportion of patients gaining at least 10 letters in the BCVA at Week 12, 24, 36 and 48

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: up to Week 12, 24, 36 and 48

  5. Proportion of patients gaining at least 5 letters in the BCVA at Week 12, 24, 36 and 48

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: up to Week 12, 24, 36 and 48

  6. • Mean change from baseline in size of CNV and total area of fluorescein leakage from CNV on FA at Week 12, 36 and 48 (as measured by the Reading Center)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: up to Week 12, 36 and 48

  7. • Mean change from baseline in CRT on OCT at Week 12, 24, 36 and 48 (as measured by the Reading Center)

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: up to week 12, 24, 36 and 48

  8. Change from baseline in NEI VFQ-25 scale score at Week 12, 36, and 48.

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: up to Week 12, 36, and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2021
  2. Study start1 Jul 2021
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04740671
Sponsor's protocol ID
HLX04-O-wAMD
Status last verified
Jan 2025
First submitted
2 Feb 2021
Last updated
3 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HLX04-O and ranibizumab in people with Age Related Macular Degeneration, run by Shanghai Henlius Biotech at 126 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 126 sites in United States, Spain, Poland, Bulgaria, China and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in BCVA at at Week 36 (time frame: up to at Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04740671.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.

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