Actively Recruiting
A Multicenter, Dose-escalation and Dose-expansion Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCT520FF in Patients With Neovascular Age-related Macular Degeneration
Led by Sinocelltech Ltd. · Updated on 2025-09-04
82
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
Sponsors
S
Sinocelltech Ltd.
Lead Sponsor
T
Tianjin Medical University Eye Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, open-label, dose-escalation and dose-expansion Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SCT520FF in patients with neovascular age-related macular degeneration (nAMD). This study aims to understand how patients with this eye condition respond to SCT520FF treatment compared to a standard treatment called EYLEA 2 mg. The trial is sponsored by Sinocelltech Ltd. and focuses on adults aged 45 to 80 years with active nAMD lesions and specific vision criteria. Participants will be randomly assigned to one of four groups: three different dose levels of SCT520FF (0.625 mg, 1.25 mg, and 2.5 mg) administered by intravitreal injection once every four weeks for three continuous treatments, or the comparator group receiving EYLEA 2 mg via injection every four weeks during the study period. The study includes dose escalation and expansion phases to assess how well patients tolerate each dose and to monitor how the drug behaves in the body. Throughout the study, participants will undergo regular assessments including monitoring of treatment-emergent and treatment-related adverse events, serious adverse events, special interest adverse events, and dose-limiting toxicities from day 0 up to 196 days. Visual acuity and central retina thickness will be measured, along with pharmacokinetic and pharmacodynamic profiles and immunogenicity. The trial ensures comprehensive safety and efficacy evaluations over the study duration, allowing detailed observation of the drug's impact on patients' eyes and overall health.
CONDITIONS
Brief Title
Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 45 to 80 years, male or female
- Study eye diagnosed with neovascular age-related macular degeneration (nAMD)
- Presence of active macular neovascularization lesions secondary to nAMD
- Total lesion area in study eye not exceeding 12 optic disc areas
- Best corrected visual acuity (BCVA) of study eye between 19 and 73 letters
You will not qualify if you...
- Macular-related retinal pigment epithelial tears, scar, fibrosis, atrophy, or dense subfoveal exudation involving the fovea in the study eye
- Significant afferent pupillary defect, refractive medium opacity, or miosis affecting vision or fundus examination in the study eye
- Aphakia (except intraocular lens) or posterior capsular rupture of the lens in the study eye
- Any eye diseases or medical history other than nAMD affecting central vision or macular examination in the study eye
- Presence of macular neovascularization caused by conditions other than nAMD in the study eye
- Active inflammation or infection in either eye before randomization
- Known allergy to any study intervention components or to fluorescein, indocyanine green, anesthetics, or antimicrobial agents used during the study
- Abnormal liver or kidney function
- Poorly controlled blood pressure before randomization
- History of cardiovascular or cerebrovascular events including myocardial infarction, unstable angina, stroke, or thromboembolic diseases within 6 months before randomization
- Significant uncontrolled concomitant diseases
- Participation in other drug or device clinical trials within 3 months or five half-lives of the study drug before randomization
- Pregnant or lactating women unable to use contraception during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive injections of SCT520FF or EYLEA 2 MG once every 4 weeks. SCT520FF is given three times continuously at different dose levels depending on assignment.
3 visits (in-person), one every 4 weeks
Duration - Up to 12 weeks after last treatment dose
Participants are monitored for safety, tolerability, and efficacy outcomes after treatment ends.
Visits as scheduled for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Eye Hospital
Tianjing, China
Actively Recruiting
Research Team
L
Li Xiaorong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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