Wet Age-related Macular DegenerationPhase 1/2NCT04564937
The Study of Drug SCT510A in Patients With Wet Age-related Macular Degeneration (wAMD)
A Phase 1/2 study testing SCT510A in people with Wet Age-related Macular Degeneration, run by Sinocelltech Ltd..
Trial summary
Multicenter ，open-label, multi-dose study to evaluate the safety and tolerability in patients with wAMD treated with intravitreal recombinant humanized anti-VEGF monoclonal antibody（SCT510A） Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Wet Age-related Macular Degeneration
- What is being tested?
- SCT510A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2020to 31 Oct 2022
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form;
- Age≥45 years，≤80 years，male or femal;
- The study eye must meet the following criteria： Diagnosis of wAMD； Primary or recurrent active subfoveal or parafoveal choroidal neovascularization (CNV) lesions secondary to AMD； Total area of all types of lesions ≤12 optic disc areas（30mm2）； Best-corrected visual acuity of the study eye 70 letters or worse(Snellen equivalent of 20/40 or worse)； No optometric media opacity and pupil shrinkage.
- Best-corrected visual acuity of the fellow eye 19 letters or better（Snellen equivalent of 20/400 or better）.
Who cannot join
- The study eye suffers structural damage of retinal which involves fovea，and the investigator assess that there is a risk of retinal detachment；
- Significant afferent pupillary defect (APD) in the study eye；
- The study eye has no lens( except intraocular lens) or posterior capsular rupture of the lens；
- In addition to AMD，there are other obvious eye diseases/conditions，such as pseudoexfoliation syndrome，rhegmatogenous retinal detachment，macular hole，diabetic retinopathy and diabetic macular disease which need to be treated；
- CNV caused by other causes other than wAMD, such as vascular stripe disease, ocular histoplasmosis, case myopia, trauma, etc；
- Uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg after antiglaucoma treatment),or recevied glaucoma filtering surgery；
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- History of vitreous hemorrhage in the study eye within 2 months before the first administration；
- Active inflammation or infection in either eye, such as conjunctivitis,keratitis, scleritis, endophthalmitis, or uveitis，ect；
- Previous intraocular surgery ，or laser therapy for wAMD(as photodynamic therapy,transpupillary thermotherapy,etc.) in the study eye within 3 months before the first administration；
- Previous intraocular or periocular injection of anti-VEGF or corticosteroid drugs (such as ranibizumab, bevacizumab, conbercept, aflibercept, brolucizumab, pegaptanib sodium, anecortave acetate, triamcinolone acetonide, etc.) in either eye within 3 months before the first administration；
- History of allergy to fluorescein sodium or indocyanine green；
- PLT≤100×109/L；thrombin time and prothrombin time exceed the upper limit of normal range (based on the laboratory normal value of clinical trial institution), and the abnormality is clinically significant according to the evaluation of the investigators；
- Abnormal liver and kidney function；
- Uncontrolled blood pressure control，systolic blood pressure≥160mmhg ,or diastolic blood pressure≥100mmhg；
- History of surgery within one month before the first administration, or current non-healing wound, ulcer, or fracture，etc；
- Patients with any of the following serious systemic diseases，such as serious mental, neurological, cardiovascular, respiratory and other system diseases and malignant tumors, systemic immune system diseases, diabetes mellitus with uncontrolled blood sugar(HbA1c>10%), disseminated intravascular coagulation and significant bleeding tendency；
- Suffering from systemic infectious diseases requiring oral, intramuscular or intravenous administration；
- Pregnant, lactating women and the patients who can not take contraceptive measures.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Open-label, Multi-dose, Phase I / II Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Efficacy and Pharmacodynamic Characteristics of SCT510A in the Patients With Wet Age-related Macular Degeneration.
Multicenter ，open-label, multi-dose study to evaluate the safety and tolerability in patients with wAMD treated with intravitreal recombinant humanized anti-VEGF monoclonal antibody（SCT510A）
- Conditions
- Wet Age-related Macular Degeneration
- Being tested
- SCT510A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCT510ADrug
SCT510A of 0.625mg、1.25mg、2.0mg、2.5mg,IVT
| Study group | Role | What they receive |
|---|---|---|
| SCT510A dose level 1 treatment | Experimental | SCT510A(0.625mg), Vitreous injection, injection once every 4 weeks，three times continuously Receives: Drug: SCT510A |
| SCT510A dose level 2 treatment | Experimental | SCT510A(1.25mg), Vitreous injection, injection once every 4 weeks，three times continuously Receives: Drug: SCT510A |
| SCT510A dose level 3 treatment | Experimental | SCT510A(2.0mg), Vitreous injection, injection once every 4 weeks，three times continuously Receives: Drug: SCT510A |
| SCT510A dose level 4 treatment | Experimental | SCT510A(2.5mg), Vitreous injection, injection once every 4 weeks，three times continuously Receives: Drug: SCT510A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting toxicity(DLT)
Incidence of dose-limiting toxicities up to the Day 14 visit
Measured: From Day 0 up to Day 14
Maximum tolerated dose(MTD）
Maximum tolerated dose
Measured: From Day 0 up to Day 140
Secondary outcomes (9)
PK profile
Change of SCT510A drug concentration in the blood with time
Measured: From Day 0 up to 84 days
Cmax
The maximum blood concentration after SCT510A drug enters the bloodstream
Measured: From Day 0 up to 84 days
Tmax
Time to the Maximum Concentration of SCT510A
Measured: From Day 0 up to 84 days
t1/2
Elimination Phase Half-life of SVT510A
Measured: From Day 0 up to 84 days
Biomarker
Detection of free VEGF concentration
Measured: From Day 0 up to 84 days
Immunogenicity
Positive rate of ADA and NAb
Measured: From Day 0 up to 112 days
central retina thickness（CRT）
Changes in CRT compared to the baseline
Measured: From Day 0 up to 140 days
Macular edema volume
Changes in Macular edema volume compared to the baseline
Measured: From Day 0 up to 140 days
Best corrected visual acuity（BCVA）
Changes in BCVA compared to the baseline
Measured: From Day 0 up to 140 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start6 Nov 2020 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564937
- Sponsor's protocol ID
- SCT510A-A101
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Multi-dose, Phase I / II Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Efficacy and Pharmacodynamic Characteristics of SCT510A in the Patients With Wet Age-related Macular Degeneration.
- ClinicalTrials.gov ID
- NCT04564937
- Acronym / sponsor ID
- SCT510A-A101
- Conditions
- Wet Age-related Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2020 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 25 Sep 2020 (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.
Multicenter ，open-label, multi-dose study to evaluate the safety and tolerability in patients with wAMD treated with intravitreal recombinant humanized anti-VEGF monoclonal antibody（SCT510A）
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SCT510A dose level 1 treatment | Experimental | Drug: SCT510ASCT510A(0.625mg), Vitreous injection, injection once every 4 weeks，three times continuously |
| SCT510A dose level 2 treatment | Experimental | Drug: SCT510ASCT510A(1.25mg), Vitreous injection, injection once every 4 weeks，three times continuously |
| SCT510A dose level 3 treatment | Experimental | Drug: SCT510ASCT510A(2.0mg), Vitreous injection, injection once every 4 weeks，three times continuously |
| SCT510A dose level 4 treatment | Experimental | Drug: SCT510ASCT510A(2.5mg), Vitreous injection, injection once every 4 weeks，three times continuously |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent form;
- Age≥45 years，≤80 years，male or femal;
- The study eye must meet the following criteria： Diagnosis of wAMD； Primary or recurrent active subfoveal or parafoveal choroidal neovascularization (CNV) lesions secondary to AMD； Total area of all types of lesions ≤12 optic disc areas（30mm2）； Best-corrected visual acuity of the study eye 70 letters or worse(Snellen equivalent of 20/40 or worse)； No optometric media opacity and pupil shrinkage.
- Best-corrected visual acuity of the fellow eye 19 letters or better（Snellen equivalent of 20/400 or better）.
Key exclusion criteria (18 listed)
- The study eye suffers structural damage of retinal which involves fovea，and the investigator assess that there is a risk of retinal detachment；
- Significant afferent pupillary defect (APD) in the study eye；
- The study eye has no lens( except intraocular lens) or posterior capsular rupture of the lens；
- In addition to AMD，there are other obvious eye diseases/conditions，such as pseudoexfoliation syndrome，rhegmatogenous retinal detachment，macular hole，diabetic retinopathy and diabetic macular disease which need to be treated；
- CNV caused by other causes other than wAMD, such as vascular stripe disease, ocular histoplasmosis, case myopia, trauma, etc；
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 |
|---|---|---|
| SCT510ASCT510A of 0.625mg、1.25mg、2.0mg、2.5mg,IVT | Drug | SCT510A dose level 1 treatment, SCT510A dose level 2 treatment, SCT510A dose level 3 treatment, SCT510A dose level 4 treatment |
Primary outcome
Dose-Limiting toxicity(DLT)
Time frame: From Day 0 up to Day 14
Incidence of dose-limiting toxicities up to the Day 14 visit
Maximum tolerated dose(MTD）
Time frame: From Day 0 up to Day 140
Maximum tolerated dose
9 secondary outcomes
PK profile
Time frame: From Day 0 up to 84 days
Cmax
Time frame: From Day 0 up to 84 days
Tmax
Time frame: From Day 0 up to 84 days
t1/2
Time frame: From Day 0 up to 84 days
Biomarker
Time frame: From Day 0 up to 84 days
Immunogenicity
Time frame: From Day 0 up to 112 days
central retina thickness（CRT）
Time frame: From Day 0 up to 140 days
Macular edema volume
Time frame: From Day 0 up to 140 days
Best corrected visual acuity（BCVA）
Time frame: From Day 0 up to 140 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SCT510A in people with Wet Age-related Macular Degeneration, run by Sinocelltech Ltd..
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 4 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Guo (+86-10-58628288-9138, ming_guo@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting toxicity(DLT) (time frame: From Day 0 up to Day 14). 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?
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 25 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.