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

A Multicenter, Open-label, Multi-dose, Phase I / II Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Efficacy and Pharmacodynamic Characteristics of SCT510A in the Patients With Wet Age-related Macular Degeneration.

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）

Study Overview

• Status: Unknown
• Conditions: Wet Age-related Macular Degeneration
• Intervention / Treatment: Drug: SCT510A

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Phase 2; Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCT510A dose level 1 treatment; SCT510A(0.625mg), Vitreous injection, injection once every 4 weeks，three times continuously	Drug: SCT510A; SCT510A of 0.625mg、1.25mg、2.0mg、2.5mg,IVT
Experimental: SCT510A dose level 2 treatment; SCT510A(1.25mg), Vitreous injection, injection once every 4 weeks，three times continuously	Drug: SCT510A; SCT510A of 0.625mg、1.25mg、2.0mg、2.5mg,IVT
Experimental: SCT510A dose level 3 treatment; SCT510A(2.0mg), Vitreous injection, injection once every 4 weeks，three times continuously	Drug: SCT510A; SCT510A of 0.625mg、1.25mg、2.0mg、2.5mg,IVT
Experimental: SCT510A dose level 4 treatment; SCT510A(2.5mg), Vitreous injection, injection once every 4 weeks，three times continuously	Drug: SCT510A; SCT510A of 0.625mg、1.25mg、2.0mg、2.5mg,IVT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sinocelltech Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 6, 2020
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: SCT510A-A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No