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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Tianjin Medical University Eye Hospital
RECRUITING
Tianjing
Contact Information
Primary
Li Xiaorong
35479080@qq.com
+86-18626789043
Time Frame
Start Date: 2024-11-26
Estimated Completion Date: 2027-01-11
Participants
Target number of participants: 82
Treatments
Experimental: SCT520FF dose level 1 treatment
SCT520FF dose level 1(0.625mg),IVI,injection once every 4 weeks,three times continuously
Experimental: SCT520FF dose level 2 treatment
SCT520FF dose level 2(1.25mg),IVI,injection once every 4 weeks,three times continuously
Experimental: SCT520FF dose level 3 treatment
SCT520FF dose level 3(2.5mg),IVI,injection once every 4 weeks,three times continuously
Active_comparator: eylea 2 mg
eylea 2 mg,IVI,injection once every 4 weeks,during the study period
Related Therapeutic Areas
Sponsors
Leads: Sinocelltech Ltd.
Collaborators: Tianjin Medical University Eye Hospital