A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI302 in Patients With Wet Age-related Macular Degeneration (AMD)

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country31 target enrollmentApril 15, 2019

ConditionsNeovascular Age-related Macular Degeneration

InterventionsIBI302

DrugsIBI302

Overview

Phase: Phase 1
Intervention: IBI302
Conditions: Neovascular Age-related Macular Degeneration
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 31
Locations: 1
Primary Endpoint: Safety evaluation indicators
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed for single-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single intravitreal injection of IBI302 in patients with wet AMD.

Registry

clinicaltrials.gov

Start Date

April 15, 2019

End Date

April 10, 2020

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patient ≥ 50 yrs. of age.
•Active subfoveal CNV secondary to wet AMD, with lesion size ≤ 12 optic discs in the study eye.
•BCVA score of 10-73 letters using ETDRS charts (in 4 meters) in the study eye.
•Central macular sub-field thickness according to OCT of at least 250 micron.
•Clear stereoscopic fundus photography is obtained while the lens or other media is clear.
•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.
•Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Exclusion Criteria

•Presence of other causes of CNV other than wet AMD in the study eye.
•Presence of active diabetic retinopathy in the study eye.
•Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment).
•Prior retinal detachment in the study eye.
•Prior any treatment of following in the study eye:
•Anti-VEGF therapy within 6 months prior to screening;
•Anti-complement therapy;
•Laser photocoagulation;
•Photodynamic therapy;
•Transpupillary thermotherapy

Arms & Interventions

cohort 1 IBI302 treated with first dose level of IBI302

Intervention: IBI302

cohort 2 IBI302 treated with second dose level of IBI302

Intervention: IBI302

cohort 3 IBI302 treated with third dose level of IBI302

Intervention: IBI302

cohort 4 IBI302 treated with fourth dose level of IBI302

Intervention: IBI302

cohort 5 IBI302 treated with fifth dose level of IBI302

Intervention: IBI302

cohort 6 IBI302 treated with sixth dose level of IBI302

Intervention: IBI302

Outcomes

Primary Outcomes

Safety evaluation indicators

Time Frame: Baseline to Day43

Decreasing of BCVA; b) Changes in intraocular pressure compared with baseline; c) Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events;