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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Biological: IBI324; Biological: IBI324; Biological: IBI324; Biological: IBI324; Biological: IBI324

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
2. Male or female subjects with age of 18~80 yrs.
3. 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.
4. Visual impairment was caused by DME involving the macular fovea.
5. Central macular sub-field thickness (CST) ≥320μm according to OCT.
6. BCVA score of 24-73 letters using ETDRS charts (in 4 meters) in the study eye.
7. 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:

1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.
2. PDR in the study eye.
3. Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular architecture in the study eye.
4. Active rubeosis in the study eye.
5. The equivalent spherical lens≤-8.00D in the study eye.
6. The intraocular pressure>21 mmHg in the study eye.
7. Active ocular or periocular inflammation/infection in either eye.

8. 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;
9. Currently untreated diabetes mellitus or previously untreated DM subjects who initiated oral or injectable antidiabetic medication or insulin <90 days;
10. HbA1c of >10% within 28 days prior to baseline;
11. Presence of any systemic disease: including but not limited to unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor;
12. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
13. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
14. Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;
15. Other conditions unsuitable for enrollment judged by investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treated with different doses of single intravitreal inmection of IBI324	Biological: IBI324; Dose 2 IBI324 of multiple IVT injection; Biological: IBI324; Dose 2 IBI324 of single IVT injection; Biological: IBI324; Dose 1 IBI324 of single IVT injection; Biological: IBI324; Dose 3 IBI324 of single IVT injection; Biological: IBI324; Dose 3 IBI324 of multiple IVT injection
Experimental: treated with different doses of multiple intravitreal inmection of IBI324	Biological: IBI324; Dose 2 IBI324 of multiple IVT injection; Biological: IBI324; Dose 2 IBI324 of single IVT injection; Biological: IBI324; Dose 1 IBI324 of single IVT injection; Biological: IBI324; Dose 3 IBI324 of single IVT injection; Biological: IBI324; Dose 3 IBI324 of multiple IVT injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of adverse events		Through study completion, a maximum of 24 weeks
Immunogenicity evaluation indicators	Positive rate of anti-drug antibody	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	Positive rate of anti-drug antibody	Through study completion, a maximum of 24 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): June 5, 2023
• Study Completion (Actual): June 5, 2023

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: CIBI324A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No