Clinical trial NCT06672536: Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients with NAMD (phase I Portion)
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 (phase I Portion)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: NAMD
Lead sponsor: Sinocelltech Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Tianjin Medical University Eye Hospital
First posted: 2024-11-04
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent form.
2. Age≥45 years, ≤80 years，male or femal.
3. 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.

Exclusion Criteria:

1. Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis, atrophy or dense subfoveal exudation involving the fovea in the study eye.
2. Significant APD or opacity of the refractive medium and miosis in the study eye that affect visual acuity or fundus examination.
3. Aphakia (except intraocular lens) or posterior capsular rupture of the lens in the study eye.
4. The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine.
5. MNV caused by non-nAMD exists in the study eye .
6. Active inflammation or infection in either eye before randomization.
7. 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.
8. Abnormal liver and kidney function.
9. Poorly-controlled blood pressure before randomization.
10. 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.
11. Evidence of significant uncontrolled concomitant diseases.
12. 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.
13. Pregnant, lactating women who can not take contraceptive measures during the trial.

Primary outcomes:
measure: Treatment emergent adverse events(TEAE)
timeFrame: From Day 0 up to 196days
measure: Treatment-related treatment emergent adverse events(TRAE)
timeFrame: From Day 0 up to 196days
measure: Serious adverse event(SAE)
timeFrame: From Day 0 up to 196days
measure: Adverse event of special interest(AESI)
timeFrame: From Day 0 up to 196days
measure: Dose limited toxicity(DLT)
timeFrame: From Day 0 up to 196days
Secondary outcomes:
measure: Best corrected visual acuity(BCVA)
timeFrame: Day 0 up to 196 days
measure: central retina thickness(CRT)
timeFrame: Day 0 up to 196days
measure: PK profile
timeFrame: Day 0 up to 196days
measure: Cmax
timeFrame: Day 0 up to 196days
measure: Tmax
timeFrame: Day 0 up to 196days
measure: PD profile
timeFrame: Day 0 up to 196 days
measure: Immunogenicity
timeFrame: Day 0 up to 196days
Other outcomes:
Locations:
Study officials:
References: