nAMDPhase 1/2NCT06672536
Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD
A Phase 1/2 study testing SCT520FF and EYLEA 2 MG in people with nAMD, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- nAMD
- What is being tested?
- SCT520FF and EYLEA 2 MG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2024to 11 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 nAMD;Active MNV lesions secondary to nAMD; Total area of all types of lesions ≤12 optic disc areas; BCVA of the study eye 73~19 letters.
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 APD or opacity of the refractive medium and miosis in the study eye that affect visual acuity or fundus examination.
- Aphakia (except intraocular lens) or posterior capsular rupture of the lens 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.
- MNV caused by non-nAMD exists in the study eye .
- Active inflammation or infection in either eye before randomization.
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- 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.
- Poorly-controlled blood pressure before randomization.
- History of a cardiovascular and cerebrovascular events, including myocardial infarction, unstable angina pectoris, cerebrovascular accidents (including TIA), other thromboembolic diseases (such as thromboembolic angiitis, etc) within 6 months before randomization.
- Evidence of significant uncontrolled concomitant diseases.
- 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 who can not take contraceptive measures during the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Eye Hospital
Tianjing
Cai Jia, 02253670982, TMUEH@163.com
About this study
Official title: A Multicenter, Dose-escalation and Dose-expansion, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy Characteristics of SCT520FF in Patients With Neovascular Age-related Macular Degeneration
Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.
- Conditions
- nAMD
- Being tested
- SCT520FF, EYLEA 2 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCT520FFDrug
SCT520FF dose level 1，IVI
SCT520FFDrug
SCT520FF dose level 2，IVI
SCT520FFDrug
SCT520FF dose level 3，IVI
EYLEA 2 MGDrug
EYLEA 2 MG,IVI,injection once every 4 weeks,during the study period
| Study group | Role | What they receive |
|---|---|---|
| SCT520FF dose level 1 treatment | Experimental | SCT520FF dose level 1(0.625mg),IVI,injection once every 4 weeks,three times continuously Receives: Drug: SCT520FF |
| SCT520FF dose level 2 treatment | Experimental | SCT520FF dose level 2(1.25mg),IVI,injection once every 4 weeks,three times continuously Receives: Drug: SCT520FF |
| SCT520FF dose level 3 treatment | Experimental | SCT520FF dose level 3(2.5mg),IVI,injection once every 4 weeks,three times continuously Receives: Drug: SCT520FF |
| eylea 2 mg | Active comparator | eylea 2 mg,IVI,injection once every 4 weeks,during the study period Receives: Drug: EYLEA 2 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events(TEAE)
Incidence of treatment emergent adverse events
Measured: From Day 0 up to 196days
Treatment-related treatment emergent adverse events(TRAE)
Incidence of treatment-related treatment emergent adverse events
Measured: From Day 0 up to 196days
Serious adverse event(SAE)
Incidence of serious adverse event
Measured: From Day 0 up to 196days
Adverse event of special interest(AESI)
Incidence of adverse event of special interest
Measured: From Day 0 up to 196days
Dose limited toxicity(DLT)
Incidence of dose-limiting toxicities
Measured: From Day 0 up to 196days
Secondary outcomes (7)
Best corrected visual acuity(BCVA)
Mean change from baseline in BCVA
Measured: Day 0 up to 196 days
central retina thickness(CRT)
Mean change from baseline in CRT
Measured: Day 0 up to 196days
PK profile
Change of SCT520FF drug concentration in the blood with time
Measured: Day 0 up to 196days
Cmax
The maximum blood concentration after SCT520FF drug enters the bloodstream
Measured: Day 0 up to 196days
Tmax
Time to the Maximum Concentration of SCT520FF
Measured: Day 0 up to 196days
PD profile
Detection of free VEGF concentration
Measured: Day 0 up to 196 days
Immunogenicity
Positive rate of ADA and NAb
Measured: Day 0 up to 196days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start26 Nov 2024
- Primary completion23 Sep 2026 (estimated)
- Study completion11 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for nAMDStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Medical University Eye Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672536
- Sponsor's protocol ID
- SCT520FF-A201
- Status last verified
- Aug 2025
- First submitted
- 29 Oct 2024
- Last updated
- 4 Sep 2025
- 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Dose-escalation and Dose-expansion, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy Characteristics of SCT520FF in Patients With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT06672536
- Acronym / sponsor ID
- SCT520FF-A201
- Conditions
- nAMD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Medical University Eye Hospital
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 23 Sep 2026 (estimated)
- Study completion
- 11 Jan 2027 (estimated)
- First posted
- 4 Nov 2024 (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 nAMD treated with SCT520FF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SCT520FF dose level 1 treatment | Experimental | Drug: SCT520FFSCT520FF dose level 1(0.625mg),IVI,injection once every 4 weeks,three times continuously |
| SCT520FF dose level 2 treatment | Experimental | Drug: SCT520FFSCT520FF dose level 2(1.25mg),IVI,injection once every 4 weeks,three times continuously |
| SCT520FF dose level 3 treatment | Experimental | Drug: SCT520FFSCT520FF dose level 3(2.5mg),IVI,injection once every 4 weeks,three times continuously |
| eylea 2 mg | Active comparator | Drug: EYLEA 2 MGeylea 2 mg,IVI,injection once every 4 weeks,during the study period |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent form.
- Age≥45 years, ≤80 years，male or femal.
- The study eye must meet the following criteria: Diagnosis of nAMD;Active MNV lesions secondary to nAMD; Total area of all types of lesions ≤12 optic disc areas; BCVA of the study eye 73~19 letters.
Key exclusion criteria (13 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 APD or opacity of the refractive medium and miosis in the study eye that affect visual acuity or fundus examination.
- Aphakia (except intraocular lens) or posterior capsular rupture of the lens 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.
- MNV caused by non-nAMD exists 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 |
|---|---|---|
| SCT520FFSCT520FF dose level 1，IVI | Drug | SCT520FF dose level 1 treatment |
| SCT520FFSCT520FF dose level 2，IVI | Drug | SCT520FF dose level 2 treatment |
| SCT520FFSCT520FF dose level 3，IVI | Drug | SCT520FF dose level 3 treatment |
| EYLEA 2 MGEYLEA 2 MG,IVI,injection once every 4 weeks,during the study period | Drug | eylea 2 mg |
Primary outcome
Treatment emergent adverse events(TEAE)
Time frame: From Day 0 up to 196days
Incidence of treatment emergent adverse events
Treatment-related treatment emergent adverse events(TRAE)
Time frame: From Day 0 up to 196days
Incidence of treatment-related treatment emergent adverse events
Serious adverse event(SAE)
Time frame: From Day 0 up to 196days
Incidence of serious adverse event
Adverse event of special interest(AESI)
Time frame: From Day 0 up to 196days
Incidence of adverse event of special interest
Dose limited toxicity(DLT)
Time frame: From Day 0 up to 196days
Incidence of dose-limiting toxicities
7 secondary outcomes
Best corrected visual acuity(BCVA)
Time frame: Day 0 up to 196 days
central retina thickness(CRT)
Time frame: Day 0 up to 196days
PK profile
Time frame: Day 0 up to 196days
Cmax
Time frame: Day 0 up to 196days
Tmax
Time frame: Day 0 up to 196days
PD profile
Time frame: Day 0 up to 196 days
Immunogenicity
Time frame: Day 0 up to 196days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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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.
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 SCT520FF and EYLEA 2 MG in people with nAMD, 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 3 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 4 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Xiaorong (+86-18626789043, 35479080@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent adverse events(TEAE) (time frame: From Day 0 up to 196days). The study lists 5 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 4 Sep 2025.