Actively Recruiting
Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD
Led by Sinocelltech Ltd. · Updated on 2025-09-04
82
Participants Needed
1
Research Sites
110 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
Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.
CONDITIONS
Official 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 nAMD and active MNV lesions secondary to nAMD
- Total area of all types of lesions 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 study eye
- Significant afferent pupillary defect, refractive medium opacity, or miosis affecting visual acuity or fundus examination in study eye
- Aphakia (except intraocular lens) or posterior capsular rupture in study eye
- Any eye disease or medical history other than nAMD affecting central vision or macular examination in study eye
- Presence of MNV caused by non-nAMD in study eye
- Active inflammation or infection in either eye before randomization
- Allergy to any study intervention component or history of allergy to fluorescein, indocyanine green, anesthetics, or antimicrobial agents
- Abnormal liver or kidney function
- Poorly controlled blood pressure before randomization
- Cardiovascular or cerebrovascular events (e.g., myocardial infarction, unstable angina, stroke, thromboembolic diseases) within 6 months before randomization
- Significant uncontrolled concomitant diseases
- Participation in other drug or device clinical trials within 3 months or 5 half-lives of 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
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Eye Hospital
Tianjing, China
Actively Recruiting
Research Team
L
Li Xiaorong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here