The Study of Drug SCT510A in Patients With Wet Age-related Macular Degeneration (wAMD)

Phase 1

• Conditions: Wet Age-related Macular Degeneration
• Interventions: Drug: SCT510A

• Registration Number: NCT04564937
• Lead Sponsor: Sinocelltech Ltd.

Brief Summary

Multicenter ，open-label, multi-dose study to evaluate the safety and tolerability in patients with wAMD treated with intravitreal recombinant humanized anti-VEGF monoclonal antibody（SCT510A）

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-21
• Last Update Submitted: 2020-09-21
• Study First Posted: 2020-09-25
• Last Update Posted: 2020-09-25
• Study Start: 2020-11-06
• Primary Completion: 2022-04-30
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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 wAMD； Primary or recurrent active subfoveal or parafoveal choroidal neovascularization (CNV) lesions secondary to AMD； Total area of all types of lesions ≤12 optic disc areas（30mm2）； Best-corrected visual acuity of the study eye 70 letters or worse(Snellen equivalent of 20/40 or worse)； No optometric media opacity and pupil shrinkage.
4. Best-corrected visual acuity of the fellow eye 19 letters or better（Snellen equivalent of 20/400 or better）.

Exclusion Criteria

1. The study eye suffers structural damage of retinal which involves fovea，and the investigator assess that there is a risk of retinal detachment；
2. Significant afferent pupillary defect (APD) in the study eye；
3. The study eye has no lens( except intraocular lens) or posterior capsular rupture of the lens；
4. In addition to AMD，there are other obvious eye diseases/conditions，such as pseudoexfoliation syndrome，rhegmatogenous retinal detachment，macular hole，diabetic retinopathy and diabetic macular disease which need to be treated；
5. CNV caused by other causes other than wAMD, such as vascular stripe disease, ocular histoplasmosis, case myopia, trauma, etc；
6. Uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg after antiglaucoma treatment),or recevied glaucoma filtering surgery；
7. History of vitreous hemorrhage in the study eye within 2 months before the first administration；
8. Active inflammation or infection in either eye, such as conjunctivitis,keratitis, scleritis, endophthalmitis, or uveitis，ect；
9. Previous intraocular surgery ，or laser therapy for wAMD(as photodynamic therapy,transpupillary thermotherapy,etc.) in the study eye within 3 months before the first administration；
10. Previous intraocular or periocular injection of anti-VEGF or corticosteroid drugs (such as ranibizumab, bevacizumab, conbercept, aflibercept, brolucizumab, pegaptanib sodium, anecortave acetate, triamcinolone acetonide, etc.) in either eye within 3 months before the first administration；
11. History of allergy to fluorescein sodium or indocyanine green；
12. PLT≤100×109/L；thrombin time and prothrombin time exceed the upper limit of normal range (based on the laboratory normal value of clinical trial institution), and the abnormality is clinically significant according to the evaluation of the investigators；
13. Abnormal liver and kidney function；
14. Uncontrolled blood pressure control，systolic blood pressure≥160mmhg ,or diastolic blood pressure≥100mmhg；
15. History of surgery within one month before the first administration, or current non-healing wound, ulcer, or fracture，etc；
16. Patients with any of the following serious systemic diseases，such as serious mental, neurological, cardiovascular, respiratory and other system diseases and malignant tumors, systemic immune system diseases, diabetes mellitus with uncontrolled blood sugar(HbA1c>10%), disseminated intravascular coagulation and significant bleeding tendency；
17. Suffering from systemic infectious diseases requiring oral, intramuscular or intravenous administration；
18. Pregnant, lactating women and the patients who can not take contraceptive measures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SCT510A dose level 1 treatment	SCT510A	SCT510A(0.625mg), Vitreous injection, injection once every 4 weeks，three times continuously
SCT510A dose level 2 treatment	SCT510A	SCT510A(1.25mg), Vitreous injection, injection once every 4 weeks，three times continuously
SCT510A dose level 3 treatment	SCT510A	SCT510A(2.0mg), Vitreous injection, injection once every 4 weeks，three times continuously
SCT510A dose level 4 treatment	SCT510A	SCT510A(2.5mg), Vitreous injection, injection once every 4 weeks，three times continuously

Primary Outcome Measures

Name	Time	Method
Dose-Limiting toxicity(DLT)	From Day 0 up to Day 14	Incidence of dose-limiting toxicities up to the Day 14 visit
Maximum tolerated dose(MTD）	From Day 0 up to Day 140	Maximum tolerated dose

Secondary Outcome Measures

Name	Time	Method
PK profile	From Day 0 up to 84 days	Change of SCT510A drug concentration in the blood with time
Cmax	From Day 0 up to 84 days	The maximum blood concentration after SCT510A drug enters the bloodstream
Tmax	From Day 0 up to 84 days	Time to the Maximum Concentration of SCT510A
Best corrected visual acuity（BCVA）	From Day 0 up to 140 days	Changes in BCVA compared to the baseline
t1/2	From Day 0 up to 84 days	Elimination Phase Half-life of SVT510A
Biomarker	From Day 0 up to 84 days	Detection of free VEGF concentration
Immunogenicity	From Day 0 up to 112 days	Positive rate of ADA and NAb
central retina thickness（CRT）	From Day 0 up to 140 days	Changes in CRT compared to the baseline
Macular edema volume	From Day 0 up to 140 days	Changes in Macular edema volume compared to the baseline