A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI333 in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country17 target enrollmentFebruary 27, 2023

ConditionsNeovascular Age-related Macular Degeneration

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Neovascular Age-related Macular Degeneration
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 17
Locations: 1
Primary Endpoint: Safety and tolerance indicators
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed for multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injection of IBI333 in subjects with neovascular age-related macular degeneration (nAMD).

Registry

clinicaltrials.gov

Start Date

February 27, 2023

End Date

April 25, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
•Male or female patients ≥ 50 yrs. of age.
•Active CNV lesions secondary to neovascular AMD.
•BCVA score of 19-78 letters using ETDRS charts in the study eye.
•Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 6 months after the end of treatment.

Exclusion Criteria

•Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
•Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye;
•Active ocular or periocular inflammation/infection in either eye;
•Prior any treatment of following in the study eye:
•Anti-VEGF therapy within 90 days prior to screening;
•Intraocular glucocorticoid injection within 180 days prior to screening;
•Laser photocoagulation or photodynamic therapy within 90 days prior to screening;
•Intraocular surgery within 90 days prior to screening;
•Laser posterior capsulotomy, laser trabeculectomy or laser peripheral iridectomy within 30 days prior to screening;
•Glycated hemoglobin (HbA1c) \> 8% within 28 days prior to screening;

Outcomes

Primary Outcomes

Safety and tolerance indicators

Time Frame: Through study completion, a maximum of 24 weeks

1. Incidence, relatedness and severity of all adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE); 2. Incidence of dose limiting toxicity;

Secondary Outcomes

Maximum concentration (Cmax) of the drug after the administration.(Through study completion, a maximum of 24 weeks)
Time at which maximum concentration (Tmax) occurs for the drug after the administration.(Through study completion, a maximum of 24 weeks)
Number of participants with anti-drug antibodies or neutralizing antibodies .(Through study completion, a maximum of 24 weeks)
Changes of CST measured by spectral domain optical coherence tomography (SD-OCT) from baseline.(Through study completion, a maximum of 24 weeks)
The area under the curve (AUC) of serum concentration of the drug after the administration.(Through study completion, a maximum of 24 weeks)
The half-life (t1/2) of drug after the administration .(Through study completion, a maximum of 24 weeks)
Changes of BCVA measured by ETDRS chart from baseline.(Through study completion, a maximum of 24 weeks)
Proportion of subjects without intraretinal or subretinal fluid on SD-OCT.(Through study completion, a maximum of 24 weeks)
Change of height of pigment epithelial detachment from baseline on SD-OCT.(Through study completion, a maximum of 24 weeks)