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Age Related Macular DegenerationPhase 3NCT05003245

Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD

A Phase 3 study testing HLX04-O，recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection and Lucentis in people with Age Related Macular Degeneration, run by Shanghai Henlius Biotech at 41 sites in China.

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 IVT with ranibizumab in patients with active CNV secondary to AMD. 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，recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection and Lucentis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
407 participants
Where
41 sitesChina
Study dates
1 Nov 2021to 7 May 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 ICF and this protocol. In the Investigator's judgment, willing and able to complete all visits and assessments adhering to the prohibitions and restrictions specified in this protocol.
  • Women or men aged ≥50 years when signing the ICF.
  • Newly diagnosed, untreated, active subfoveal or juxtafoveal CNV lesions secondary to AMD in the study eye. (Active CNV was defined as leakage on FA and subretinal or intraretinal fluid on 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 a.
  • The BCVA letters between 24 and 73, inclusive, in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
  • Clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm the diagnosis.
  • Participants' fellow (non-study) eye must have had a BCVA of 24 letters or better.

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, or pathological myopia etc.) with confirmation of the reading center.
  • The fellow (nonstudy) 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.
  • 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.
  • Aphakia (except intraocular lens) or posterior capsular rupture of the lens (except yttrium aluminium-garnet (YAG) laser posterior capsulotomy after intraocular lens implantation ≥1 month prior to first dose) in the study eye.
  • 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.
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  • Uncontrolled glaucoma (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.), or advanced glaucoma resulting in a cup/disc ratio >0.8 in the study eye
  • 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 (including cataract surgery, etc.) within 3 months prior to dose 1, or current unhealed wound, moderate or severe ulcer or history of fracture in the study eye.
  • Subconjunctival or intraocular or systemic use of corticosteroids within 3 months (including subconjunctival or intraocular long-acting implant within 6 months) prior to dose 1 in the study eye.
  • 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 within 3 months or the duration of 5 half-lives of the study drug (which is longer) prior to dose 1 and have used the test drug or received device treatment.
  • Pregnancy or lactation.
  • Infertile women 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.
  • Men or fertile women fail to meet both 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 the study intervention. Effective contraceptive methods include 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 todose1, 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 ≥ 3 seconds over ULN, activated partial thromboplastin time ≥ 10 seconds over ULN）
  • 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.
  • 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 or positive for human immunodeficiency virus (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 or who has received COVID-19 vaccine within 1 month prior to dose 1.
  • Other protocol defined inclusion and exclusion criteria may apply.

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

China41 sites

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • The first affiliated hospital of bengbu medical college

    Bengbu, Anhui

  • Cangzhou Central Hospital

    Cangzhou, Hebei

  • The First Affiliated Hospital of Third Military Medical University (Southwest Hospital)

    Chongqing, Chongqing Municipality

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital )

    Guangzhou, Guangdong

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • Zhejiang provincial people's hospital

    Hangzhou, Zhejiang

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Jieyang People's Hospital

    Jieyang, Guangdong

  • The First Hospital of Jilin University

    Jilin City, Jilin

  • Shangdong Provincial Hospital

    Jinan, Shandong

  • The Second Hospital of Lanzhou University

    Lanzhou, Gansu

  • Lishui Municioal Central Hospital

    Lishui, Zhejiang

  • Luoyang Third People's Hospital

    Luoyang, Henan

  • Affiliated Eye Hospital of Nanchang University

    Nanchang, Jiangxi

  • the First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • The First Affiliated Hospital of Guangxi Medical University

    Nanjing, Guangxi

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200233

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality

  • Shenyang AIER Eye Hospital

    Shenyang, Liaoning

  • Shanxi Eye Hospital

    Taiyuan, Shanxi

  • Tianjin Eye Hospital

    Tianjin, Tianjin Municipality

  • Weifang Eye Hospital

    Weifang, Shandong

  • People's Hospital of Wuhan University (Hubei Provincial People's Hospital)

    Wuhan, Hubei

  • Tongji hospital, Tongji medical college, Huazhong University of Science and Technology

    Wuhan, Hubei

  • Wuhan AIER Eye Hospital

    Wuhan, Hubei

  • Wuhan Puren Hospital

    Wuhan, Hubei

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan

  • The Third Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan

  • Yichang Central People's Hospital

    Yichang, Hubei

  • Ningxia Hui Autonomous Region Peoples Hospital

    Yinchuan, Ningxia

  • Henan Eye Hospital

    Zhengzhou, Henan

  • The First People's Hospital of Zunyi

    Zunyi, Guizhou

Other trials in China

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 IVT with ranibizumab in patients with active CNV secondary to AMD.

Read the detailed description

This is a Phase 3, multicenter, randomized double masked active controlled study to compare the efficacy and safety of HLX04-O administered by IVT with ranibizumab in patients with active CNV secondary to AMD. The study will be conducted in approximately 60 sites in China.

Either HLX04-O (1.25 mg) IVT or ranibizumab (0.5 mg) IVT will be administered at a 4-week interval for 1 year (12 cycles).

Being tested
HLX04-O，recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection, Lucentis
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-O，recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injectionDrug

    0.05mL solution at a 4-week interval for intravitreal injection

  • LucentisDrug

    0.05mL solution at a 4-week interval for intravitreal injection

Study groups in NCT05003245
Study groupRoleWhat they receive
HLX04-OExperimentalBiologic recombinant anti-VEGF humanized monoclonal antibody
Receives: Drug: HLX04-O，recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection
RanibizumabActive comparatorBiologic anti-VEGF recombinant humanized monoclonal antibody fragment
Receives: Drug: Lucentis

What is being measured

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

  1. Mean change of letters from baseline in best-corrected visual acuity (BCVA) at Week 48.

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: from baseline to week 48

Secondary outcomes (8)

  1. Mean change of letters from baseline in the BCVA over time

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From baseline to week 48

  2. Proportion of patients gaining at least 15/10/5 letters in the BCVA at Week 12, 24, 36 and 48

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From baseline to week 48

  3. Mean change from baseline in the total area of CNV and the total area of fluorescein leakage on fluorescein angiography (FA) at Week 12, 24 and 48

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From baseline to week 48

  4. Mean change from baseline in central retina thickness (CRT) on optical coherence tomography (OCT) at Week 12, 24, 36 and 48

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From baseline to week 48

  5. Change from baseline in National Eye Institute Visual Functioning Questionnaire - 25 scale score at Week 12, 24, and 48

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From baseline to week 48

  6. Percentage and severity of ocular AEs (IVT procedure related and Investigation Medication related), non-ocular AEs; laboratory abnormalities; vital sign, physical examination abnormalities, etc.

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From baseline to week 48

  7. Incidence of ADAs and NAbs against HLX04-O following IVT administration

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From baseline to week 48

  8. HLX04-O serum concentrations before Dose 1, Dose 2, Dose 6, Dose 9 and Dose 12 and the last visit as data permit.

    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

    Measured: From baseline to week 48

Timeline

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

  1. First posted12 Aug 2021
  2. Study start1 Nov 2021
  3. Primary completion7 May 2024
  4. Study completion7 May 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
407 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05003245
Sponsor's protocol ID
HLX04-O-wAMD-CN
Status last verified
Mar 2025
First submitted
8 Jul 2021
Last updated
24 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
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，recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection and Lucentis in people with Age Related Macular Degeneration, run by Shanghai Henlius Biotech at 41 sites in China.

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 7 inclusion and 30 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 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in China. 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 of letters from baseline in best-corrected visual acuity (BCVA) at Week 48. (time frame: from baseline to week 48). 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 NCT05003245.

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 24 Mar 2025.

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