A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema

NCT05489718 | Completed Phase 1 DMC

• 1 other identifier: CIBI324A101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Safety evaluation indicators

  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

  Through study completion, a maximum of 24 weeks

Secondary Outcomes (5)

• The incidence of adverse events

  Through study completion, a maximum of 24 weeks

• 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

• Immunogenicity evaluation indicators

  Through study completion, a maximum of 24 weeks

Study Arms (2)

treated with different doses of single intravitreal inmection of IBI324

EXPERIMENTAL

Biological: IBI324

treated with different doses of multiple intravitreal inmection of IBI324

EXPERIMENTAL

Biological: IBI324

Interventions

IBI324 BIOLOGICAL

Dose 2 IBI324 of multiple IVT injection

treated with different doses of multiple intravitreal inmection of IBI324

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• PRP, local/grid laser photocoagulation within 3 months prior to baseline;
• Any intraocular surgery (e.g. cataract surgery) within 90 days prior to baseline;
• The eyes were treated with lasik posterior capsulotomy or glaucoma filtration, radiotherapy 30 days before baseline;
• Currently untreated diabetes mellitus or previously untreated DM subjects who initiated oral or injectable antidiabetic medication or insulin \<90 days;
• HbA1c of \>10% within 28 days prior to baseline;

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (1)

• Wang Z, Sun J, Liu K, Tao L, Liu Q, Wu M, Lu S, Deng J, Li L, Qian L, Li X, Sun X. Phase 1 dose-escalation study of IBI324, a VEGF-A/Ang-2 bispecific antibody, for the treatment of diabetic macular oedema. BMJ Open Ophthalmol. 2026 Jan 5;11(1):e002035. doi: 10.1136/bmjophth-2024-002035.

  PMID: 41494748 DERIVED

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: June 21, 2022
• First Posted: August 5, 2022
• Study Start: August 1, 2022
• Primary Completion: June 5, 2023
• Study Completion: June 5, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

CN (1)