Wet Age-related Macular DegenerationPhase 3NCT05480293
This Study Will Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection (IVT) With Ranibizumab in Patients With wAMD
A Phase 3 study testing Ranibizumab and SCT510A in people with Wet Age-related Macular Degeneration, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
The purpose of this study is to compare the efficacy and safety of SCT510A versus Lucentis in the treatment of wet age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Wet Age-related Macular Degeneration
- What is being tested?
- Ranibizumab and SCT510A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2023to 31 Aug 2025
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form;
- Age≥45 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 wAMD； The total lesion area ≤ 30mm2； The BCVA letters between 19 and 73, inclusive, in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts；
- The study eye has not received any anti-VEGF treatment within 3 months before randomization, such as ranibizumab, bevacizumab, conbercept, etc；
Who cannot join
- Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis, atrophy or dense subfoveal exudation involving the fovea in the study eye;
- Significant afferent pupillary defect (APD) in the study eye；
- 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 before randomization) in the study eye.
- The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine (diabetic retinopathy, retinal vein occlusion, retinal detachment, macular hole, macular epiretinal membrane, vitreous macular traction syndrome, optic nerve disease, etc.);
- CNV caused by non-nAMD exists in the study eye (such as trauma, ocular histoplasmosis, vascular stripes, etc.);
- The study eye has high myopia with diopter≥8D;
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- The study eye has poorly controlled glaucoma (defined as intraocular pressure≥25 mmHg after anti-glaucoma treatment), or has received glaucoma filtering surgery;
- Vitreous hemorrhage in the study eye before randomization;
- Any history of the following ophthalmic surgery in the study eye: vitrectomy, macular transposition; any evidence of external eye surgery within 1 month, cataract surgery within 2 months or other intraocular surgery within 3 months before randomization in the study eye;
- Active inflammation or infection in either eye, such as conjunctivitis,keratitis, scleritis, or endophthalmitis, ect；
- Previous IVT injection of any anti-VEGF drug into fellow eye within 3 months before randomization;
- Fellow eye uses ETDRS testing to detect BCVA <19 letters;
- 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;
- Abnormal liver and kidney function (ALT, AST≥2.5 times the upper limit of normal; total bilirubin≥1.5 times the upper limit of normal; serum creatinine≥1.5 times the upper limit of normal);Abnormal coagulation function（prothrombin time ≥ 3 seconds over ULN, activated partial thromboplastin time ≥ 10 seconds over ULN）;
- Poorly-controlled blood pressure (defined as: after receiving antihypertensive drugs, the subject's systolic value ≥160 mmHg or diastolic value ≥100 mmHg at seat);
- History of a medical condition, including myocardial infarction, unstable angina pectoris, cerebrovascular accidents (including TIA), other thromboembolic diseases (such as thromboembolic angiitis, pulmonary embolism, deep vein thrombosis, portal vein thrombosis, etc.) within 6 months before randomization;
- Any history of surgery within 1 month before randomization, and/or any currently unhealed wounds, ulcers, fractures, etc.;
- 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 before randomization; uncontrolled diabetes (defined as HbA1c>10.0%);current treatment for active systemic infection;
- 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) before randomization and have used the test drug or received device treatment.
- Pregnant, lactating women and the patients who can not take contraceptive measures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Multicenter, Randomized, Double-Masked, Parallel Controlled, Non Inferior Study to Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection With Ranibizumab in Subjects With Wet Age-related Macular Degeneration (wAMD)
The purpose of this study is to compare the efficacy and safety of SCT510A versus Lucentis in the treatment of wet age-related macular degeneration.
- Conditions
- Wet Age-related Macular Degeneration
- Being tested
- Ranibizumab, SCT510A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
ranibizumab，0.5mg,IVT
SCT510ADrug
SCT510A，1.25mg,IVT
| Study group | Role | What they receive |
|---|---|---|
| SCT510A | Experimental | SCT510A(1.25mg), Vitreous injection, injection once every 4 weeks Receives: Drug: SCT510A |
| Ranibizumab | Active comparator | Ranibizumab(0.5mg), Vitreous injection, injection once every 4 weeks Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in BCVA at at Week 48
Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score at week 48.
Measured: up to at Week 48
Secondary outcomes (4)
Proportion of patients gaining at least 5，10，15 letters in the BCVA at Week 12, 24 and 48
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Measured: up to Week 12, 24 and 48
Mean change from baseline in BCVA at at Week 12 and 24
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Measured: up to Week 12 and 24
Mean change from baseline in CRT on OCT at Week 12, 24 and 48 (as measured by the Reading Center)
Measured: up to Week 12,24 and 48
Mean change from baseline in size of CNV and total area of fluorescein leakage from CNV on FA at Week 12 and 48 (as measured by the Reading Center)
Measured: up to Week 12 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start14 Feb 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Aug 2025 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 446 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
- NCT05480293
- Sponsor's protocol ID
- SCT510A-A301
- Status last verified
- May 2022
- First submitted
- 28 Jul 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-Masked, Parallel Controlled, Non Inferior Study to Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection With Ranibizumab in Subjects With Wet Age-related Macular Degeneration (wAMD)
- ClinicalTrials.gov ID
- NCT05480293
- Acronym / sponsor ID
- SCT510A-A301
- Conditions
- Wet Age-related Macular Degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 446 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 29 Jul 2022 (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.
The purpose of this study is to compare the efficacy and safety of SCT510A versus Lucentis in the treatment of wet age-related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCT510A | Experimental | Drug: SCT510ASCT510A(1.25mg), Vitreous injection, injection once every 4 weeks |
| Ranibizumab | Active comparator | Drug: RanibizumabRanibizumab(0.5mg), Vitreous injection, injection once every 4 weeks |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent form;
- Age≥45 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 wAMD； The total lesion area ≤ 30mm2； The BCVA letters between 19 and 73, inclusive, in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts；
- The study eye has not received any anti-VEGF treatment within 3 months before randomization, such as ranibizumab, bevacizumab, conbercept, etc；
Key exclusion criteria (20 listed)
- Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis, atrophy or dense subfoveal exudation involving the fovea in the study eye;
- Significant afferent pupillary defect (APD) in the study eye；
- 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 before randomization) in the study eye.
- The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine (diabetic retinopathy, retinal vein occlusion, retinal detachment, macular hole, macular epiretinal membrane, vitreous macular traction syndrome, optic nerve disease, etc.);
- CNV caused by non-nAMD exists in the study eye (such as trauma, ocular histoplasmosis, vascular stripes, 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 |
|---|---|---|
| Ranibizumabranibizumab，0.5mg,IVT | Drug | Ranibizumab |
| SCT510ASCT510A，1.25mg,IVT | Drug | SCT510A |
Primary outcome
Mean change from baseline in BCVA at at Week 48
Time frame: up to at Week 48
Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score at week 48.
4 secondary outcomes
Proportion of patients gaining at least 5，10，15 letters in the BCVA at Week 12, 24 and 48
Time frame: up to Week 12, 24 and 48
Mean change from baseline in BCVA at at Week 12 and 24
Time frame: up to Week 12 and 24
Mean change from baseline in CRT on OCT at Week 12, 24 and 48 (as measured by the Reading Center)
Time frame: up to Week 12,24 and 48
Mean change from baseline in size of CNV and total area of fluorescein leakage from CNV on FA at Week 12 and 48 (as measured by the Reading Center)
Time frame: up to Week 12 and 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ranibizumab and SCT510A in people with Wet Age-related Macular Degeneration, run by Sinocelltech Ltd. 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 4 inclusion and 20 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 16 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Guo (+86-10-58628288-9127, ming_guo@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in BCVA at at Week 48 (time frame: up to at Week 48). 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 16 Feb 2023.