A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI324 in Subjects With Diabetic Macular Edema(DME)

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country24 target enrollmentAugust 1, 2022

ConditionsDiabetic Macular Edema

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Diabetic Macular Edema
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 24
Locations: 1
Primary Endpoint: Safety evaluation indicators
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed as a Multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injections of IBI324 in subjects with DME

Registry

clinicaltrials.gov

Start Date

August 1, 2022

End Date

June 5, 2023

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 subjects with age of 18\~80 yrs.
•Diagnosis of diabetes mellitus(type 1 or 2), and current regular use of insulin or other injectable drugs or oral anti-hyperglycaemic agent for the treatment of diabetes.
•Visual impairment was caused by DME involving the macular fovea.
•Central macular sub-field thickness (CST) ≥320μm according to OCT.
•BCVA score of 24-73 letters using ETDRS charts (in 4 meters) 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 3 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.
•PDR in the study eye.
•Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular architecture in the study eye.
•Active rubeosis in the study eye.
•The equivalent spherical lens≤-8.00D in the study eye.
•The intraocular pressure\>21 mmHg in the study eye.
•Active ocular or periocular inflammation/infection in either eye.
•Prior any treatment of following in the study eye:
•Intravitreal anti-VEGF treatment within 3 months prior to baseline;
•Intraocular glucocorticoid injection within 3 months prior to baseline;

Outcomes

Primary Outcomes

Safety evaluation indicators

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

Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events b) Changes in central subfield thickness by OCT compared with baseline

Secondary Outcomes

Changes in visual acuity as measured by BCVA compared with baseline(Through study completion, a maximum of 24 week)
Changes in the average thickness of the macula in the central 1 mm ETDRS grid (CST) compared with baseline(Through study completion, a maximum of 24 week)
Pharmacokinetic (PK) profiles, such as half-life time (t1/2)，etc(Through study completion, a maximum of 24 weeks)
The incidence of adverse events(Through study completion, a maximum of 24 weeks)
Immunogenicity evaluation indicators(Through study completion, a maximum of 24 weeks)