Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD

NCT06672536 | Recruiting Phase 1

• 1 other identifier: SCT520FF-A201
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

nAMD

Outcome Measures

Primary Outcomes (5)

• Treatment emergent adverse events(TEAE)

  Incidence of treatment emergent adverse events

  From Day 0 up to 196days

• Treatment-related treatment emergent adverse events(TRAE)

  Incidence of treatment-related treatment emergent adverse events

  From Day 0 up to 196days

• Serious adverse event(SAE)

  Incidence of serious adverse event

  From Day 0 up to 196days

• Adverse event of special interest(AESI)

  Incidence of adverse event of special interest

  From Day 0 up to 196days

• Dose limited toxicity(DLT)

  Incidence of dose-limiting toxicities

  From Day 0 up to 196days

Secondary Outcomes (7)

• Best corrected visual acuity(BCVA)

  Day 0 up to 196 days

• central retina thickness(CRT)

  Day 0 up to 196days

• PK profile

  Day 0 up to 196days

• Cmax

  Day 0 up to 196days

• Tmax

  Day 0 up to 196days

Study Arms (4)

SCT520FF dose level 1 treatment

EXPERIMENTAL

SCT520FF dose level 1(0.625mg),IVI,injection once every 4 weeks,three times continuously

Drug: SCT520FF

SCT520FF dose level 2 treatment

EXPERIMENTAL

SCT520FF dose level 2(1.25mg),IVI,injection once every 4 weeks,three times continuously

Drug: SCT520FF

SCT520FF dose level 3 treatment

EXPERIMENTAL

SCT520FF dose level 3(2.5mg),IVI,injection once every 4 weeks,three times continuously

Drug: SCT520FF

eylea 2 mg

ACTIVE COMPARATOR

eylea 2 mg,IVI,injection once every 4 weeks,during the study period

Drug: EYLEA 2 MG

Interventions

SCT520FF DRUG

SCT520FF dose level 1，IVI

SCT520FF dose level 1 treatment

EYLEA 2 MG DRUG

EYLEA 2 MG,IVI,injection once every 4 weeks,during the study period

eylea 2 mg

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead
• Tianjin Medical University Eye Hospital: collaborator

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjing, China

RECRUITING

MeSH Terms

Interventions

aflibercept

Central Study Contacts

Li Xiaorong

CONTACT

+86-18626789043; 35479080@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 4, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): January 11, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

CN (1)