Age Related Macular DegenerationPhase 1/2NCT04993352
Evaluate the Safety and Efficacy of HLX04-O in Subjects With wAMD
A Phase 1/2 study testing recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection in people with Age Related Macular Degeneration, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HLX04-O administered every 4 weeks in participants with wet age-related macular degeneration (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?
- recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2021to 13 Mar 2023
- Phase
- Phase 1/2
- 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 fully understand and sign the informed consent form (ICF).
- Women or men aged ≥50 years when signing the ICF.
- Newly diagnosed or recurrently, 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).
- The total lesion area (including bleeding, scar and neovascularization) of the study eye ≤12 disc area (DA).
- The BCVA letters between 15 and 78, 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.
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.).
- 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, in the investigator's judgment.
- Active or recent (within 1 month prior to dose 1) intraocular, extraocular or periocular infection (including but not limited to conjunctivitis, keratitis, scleritis or endophthalmitis), or history of idiopathic or autoimmune-associated uveitis in either eye.
- Vitreous hemorrhage in 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.).
- 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, macular 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 intraocular or periocular surgery within 1 month prior to dose 1(including laser photocoagulation in juxtafoveal, cataract surgery, etc.), 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).
- Previous systemic anti-VEGF therapy or IVT injection of any anti-VEGF drug into either eye or other ocular use of anti-VEGF drug (ranibizumab, aflibercept or conbercept) 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.
- Men or women fail to meet both of the following ones: 1) women must have a negative serum pregnancy test result within 14 days prior to initiation of the study intervention; 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 physical contraception and copper intrauterine devices (IUDs).
- 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 ≥ 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(only for patients who cannot undergo OCT-A examination but have to undergo ICGA examination) or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study.
- Participant who has been diagnosed to be COVID-19 within 1 month prior to dose 1 or who has received COVID-19 vaccine within 1week prior to dose 1.
- 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, or other conditions considered not amenable to this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II, Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of HLX04-O Administered by Intravitreal Injection in Subjects With Wet Age Related Macular Degeneration (wAMD)
This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HLX04-O administered every 4 weeks in participants with wet age-related macular degeneration (wAMD)
Read the detailed description
This is a Phase I/II, Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of HLX04-O Administered by Intravitreal Injection in Subjects with wet Age related Macular Degeneration (wAMD).The study will be conducted in approximately 6 sites in China.
- Conditions
- Age Related Macular Degeneration
- Being tested
- recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injectionDrug
0.05mL (12.5mg/0.5mL/vial) HLX-04-O solution at a 4-week interval for intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| HLX04-O | Experimental | Biologic recombinant anti-VEGF humanized monoclonal antibody. Receives: Drug: recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Safety events
toxicity and causality (related to or possibly related to HLX04 O) that occurs within 4 weeks after the first treatment (single administration)
Measured: week 4
Phase 2: Mean change of letters from baseline in the BCVA at Week 12
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Week 12
Secondary outcomes (9)
Phase I: HLX04-O systemic PK parameters following IVT administration of Dose 1 and Dose 4
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: 1 year
Phase 2: Mean change of letters from baseline in the BCVA over time
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: 1 year
Phase 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: 1 year
Phase 2: 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: 1 year
Phase 2: 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: 1 year
Phase 2: Change from baseline in NEI VFQ-25 scale score at Week 12, 24, and 48
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: 1 year
Phase 2: 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: 1 year
Phase 2: Incidence of ADAs and NAbs against HLX04-O following IVT administration
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: 1 year
Phase 2: • HLX04-O serum concentrations before Dose 1, 168 hours after Dose 1, before Dose 2, before Dose 4, 168 hours after Dose 4, before Dose 5, before Dose 8, before Dose 12 and the last visit
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start15 Jul 2021
- Primary completion7 Jul 2022
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993352
- Sponsor's protocol ID
- HLX04-O-wAMD-CN01
- Status last verified
- Oct 2023
- First submitted
- 8 Jul 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Z, Wu Y, Lyu YL, Chang MQ, Xu QJ, Liu YM, Kang WY, Wang QY, Li CL. Efficacy and safety of intravitreal HLX04-O, an anti-VEGF monoclonal antibody, for the treatment of wet age-related macular degeneration. Int J Ophthalmol. 2022 Sep 18;15(9):1549-1553. doi: 10.18240/ijo.2022.09.20. eCollection 2022.
PubMed 36124180
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of HLX04-O Administered by Intravitreal Injection in Subjects With Wet Age Related Macular Degeneration (wAMD)
- ClinicalTrials.gov ID
- NCT04993352
- Acronym / sponsor ID
- HLX04-O-wAMD-CN01
- Conditions
- Age Related Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HLX04-O administered every 4 weeks in participants with wet age-related macular degeneration (wAMD)
Detailed description
This is a Phase I/II, Single-arm, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of HLX04-O Administered by Intravitreal Injection in Subjects with wet Age related Macular Degeneration (wAMD).The study will be conducted in approximately 6 sites in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLX04-O | Experimental | Drug: recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injectionBiologic recombinant anti-VEGF humanized monoclonal antibody. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Capable to fully understand and sign the informed consent form (ICF).
- Women or men aged ≥50 years when signing the ICF.
- Newly diagnosed or recurrently, 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).
- The total lesion area (including bleeding, scar and neovascularization) of the study eye ≤12 disc area (DA).
- The BCVA letters between 15 and 78, inclusive, in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Key exclusion criteria (28 listed)
- 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.).
- 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, in the investigator's judgment.
- Active or recent (within 1 month prior to dose 1) intraocular, extraocular or periocular infection (including but not limited to conjunctivitis, keratitis, scleritis or endophthalmitis), or history of idiopathic or autoimmune-associated uveitis in either eye.
- Vitreous hemorrhage in 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection0.05mL (12.5mg/0.5mL/vial) HLX-04-O solution at a 4-week interval for intravitreal injection | Drug | HLX04-O |
Primary outcome
Phase I: Safety events
Time frame: week 4
toxicity and causality (related to or possibly related to HLX04 O) that occurs within 4 weeks after the first treatment (single administration)
Phase 2: Mean change of letters from baseline in the BCVA at Week 12
Time frame: Week 12
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
9 secondary outcomes
Phase I: HLX04-O systemic PK parameters following IVT administration of Dose 1 and Dose 4
Time frame: 1 year
Phase 2: Mean change of letters from baseline in the BCVA over time
Time frame: 1 year
Phase 2: Proportion of patients gaining at least 15/10/5 letters in the BCVA at Week 12, 24, 36 and 48
Time frame: 1 year
Phase 2: 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
Time frame: 1 year
Phase 2: Mean change from baseline in central retina thickness (CRT) on optical coherence tomography (OCT) at Week 12, 24, 36 and 48
Time frame: 1 year
Phase 2: Change from baseline in NEI VFQ-25 scale score at Week 12, 24, and 48
Time frame: 1 year
Phase 2: Percentage and severity of ocular AEs (IVT procedure related and Investigation Medication related), non-ocular AEs; laboratory abnormalities; vital sign, physical examination abnormalities, etc.
Time frame: 1 year
Phase 2: Incidence of ADAs and NAbs against HLX04-O following IVT administration
Time frame: 1 year
Phase 2: • HLX04-O serum concentrations before Dose 1, 168 hours after Dose 1, before Dose 2, before Dose 4, 168 hours after Dose 4, before Dose 5, before Dose 8, before Dose 12 and the last visit
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 36124180Zhang Z, Wu Y, Lyu YL, Chang MQ, Xu QJ, Liu YM, Kang WY, Wang QY, Li CL. Efficacy and safety of intravitreal HLX04-O, an anti-VEGF monoclonal antibody, for the treatment of wet age-related macular degeneration. Int J Ophthalmol. 2022 Sep 18;15(9):1549-1553. doi: 10.18240/ijo.2022.09.20. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection in people with Age Related Macular Degeneration, run by Shanghai Henlius Biotech at 1 site 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 6 inclusion and 28 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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Phase I: Safety events (time frame: week 4). The study lists 2 primary outcomes in all. 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 NCT04993352, which also lists 1 linked publication.
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 23 Oct 2023.