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

NCT04564937 | Unknown Phase 1

• 1 other identifier: SCT510A-A101
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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）

Conditions

Wet Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• PK profile

  From Day 0 up to 84 days

• Cmax

  From Day 0 up to 84 days

• Tmax

  From Day 0 up to 84 days

• t1/2

  From Day 0 up to 84 days

• Biomarker

  From Day 0 up to 84 days

Study Arms (4)

SCT510A dose level 1 treatment

EXPERIMENTAL

SCT510A(0.625mg), Vitreous injection, injection once every 4 weeks，three times continuously

Drug: SCT510A

SCT510A dose level 2 treatment

EXPERIMENTAL

SCT510A(1.25mg), Vitreous injection, injection once every 4 weeks，three times continuously

Drug: SCT510A

SCT510A dose level 3 treatment

EXPERIMENTAL

SCT510A(2.0mg), Vitreous injection, injection once every 4 weeks，three times continuously

Drug: SCT510A

SCT510A dose level 4 treatment

EXPERIMENTAL

SCT510A(2.5mg), Vitreous injection, injection once every 4 weeks，three times continuously

Drug: SCT510A

Interventions

SCT510A DRUG

SCT510A of 0.625mg、1.25mg、2.0mg、2.5mg,IVT

SCT510A dose level 1 treatment; SCT510A dose level 2 treatment; SCT510A dose level 3 treatment; SCT510A dose level 4 treatment

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form;
• Age≥45 years，≤80 years，male or femal;
• 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.
• Best-corrected visual acuity of the fellow eye 19 letters or better（Snellen equivalent of 20/400 or better）.

You may not qualify if:

• The study eye suffers structural damage of retinal which involves fovea，and the investigator assess that there is a risk of retinal detachment；
• Significant afferent pupillary defect (APD) in the study eye；
• The study eye has no lens( except intraocular lens) or posterior capsular rupture of the lens；
• 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；
• CNV caused by other causes other than wAMD, such as vascular stripe disease, ocular histoplasmosis, case myopia, trauma, etc；
• Uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg after antiglaucoma treatment),or recevied glaucoma filtering surgery；
• History of vitreous hemorrhage in the study eye within 2 months before the first administration；
• Active inflammation or infection in either eye, such as conjunctivitis,keratitis, scleritis, endophthalmitis, or uveitis，ect；
• 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；
• 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；
• History of allergy to fluorescein sodium or indocyanine green；
• 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；
• Abnormal liver and kidney function；
• Uncontrolled blood pressure control，systolic blood pressure≥160mmhg ,or diastolic blood pressure≥100mmhg；
• History of surgery within one month before the first administration, or current non-healing wound, ulcer, or fracture，etc；

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Central Study Contacts

Ming Guo

CONTACT

+86-10-58628288-9138; ming_guo@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 25, 2020
• Study Start: November 6, 2020
• Primary Completion: April 30, 2022
• Study Completion: October 31, 2022
• Last Updated: September 25, 2020

Record last verified: 2020-09