nAMD
Conditions
Brief summary
Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.
Interventions
DRUGSCT520FF
SCT520FF dose level 1，IVI
DRUGEYLEA 2 MG
EYLEA 2 MG,IVI,injection once every 4 weeks,during the study period
Sponsors
Tianjin Medical University Eye Hospital
Sinocelltech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment emergent adverse events(TEAE) | From Day 0 up to 196days | Incidence of treatment emergent adverse events |
| Treatment-related treatment emergent adverse events(TRAE) | From Day 0 up to 196days | Incidence of treatment-related treatment emergent adverse events |
| Serious adverse event(SAE) | From Day 0 up to 196days | Incidence of serious adverse event |
| Adverse event of special interest(AESI) | From Day 0 up to 196days | Incidence of adverse event of special interest |
| Dose limited toxicity(DLT) | From Day 0 up to 196days | Incidence of dose-limiting toxicities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity(BCVA) | Day 0 up to 196 days | Mean change from baseline in BCVA |
| Tmax | Day 0 up to 196days | Time to the Maximum Concentration of SCT520FF |
| central retina thickness(CRT) | Day 0 up to 196days | Mean change from baseline in CRT |
| PD profile | Day 0 up to 196 days | Detection of free VEGF concentration |
| Immunogenicity | Day 0 up to 196days | Positive rate of ADA and NAb |
| PK profile | Day 0 up to 196days | Change of SCT520FF drug concentration in the blood with time |
| Cmax | Day 0 up to 196days | The maximum blood concentration after SCT520FF drug enters the bloodstream |
Countries
China
Contacts
Primary ContactLi Xiaorong
Outcome results
None listed