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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04564937
Other study ID # SCT510A-A101
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 6, 2020
Est. completion date October 31, 2022

Study information

Verified date September 2020
Source Sinocelltech Ltd.
Contact Ming Guo
Phone +86-10-58628288-9138
Email ming_guo@sinocelltech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 66
Est. completion date October 31, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 45 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
SCT510A
SCT510A of 0.625mg?1.25mg?2.0mg?2.5mg,IVT

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sinocelltech Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary Dose-Limiting toxicity(DLT) Incidence of dose-limiting toxicities up to the Day 14 visit From Day 0 up to Day 14
Primary Maximum tolerated dose(MTD) Maximum tolerated dose From Day 0 up to Day 140
Secondary PK profile Change of SCT510A drug concentration in the blood with time From Day 0 up to 84 days
Secondary Cmax The maximum blood concentration after SCT510A drug enters the bloodstream From Day 0 up to 84 days
Secondary Tmax Time to the Maximum Concentration of SCT510A From Day 0 up to 84 days
Secondary t1/2 Elimination Phase Half-life of SVT510A From Day 0 up to 84 days
Secondary Biomarker Detection of free VEGF concentration From Day 0 up to 84 days
Secondary Immunogenicity Positive rate of ADA and NAb From Day 0 up to 112 days
Secondary central retina thickness(CRT) Changes in CRT compared to the baseline From Day 0 up to 140 days
Secondary Macular edema volume Changes in Macular edema volume compared to the baseline From Day 0 up to 140 days
Secondary Best corrected visual acuity(BCVA) Changes in BCVA compared to the baseline From Day 0 up to 140 days
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