A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）

NCT06908876 | Recruiting Phase 2

• 1 other identifier: CIBI302B202
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed for multi-center,randomized,double-masked,active-contralledstudy to evaluate effective and security of intravitrealinjection of IBI302 in subjects with Diabetic Macular Oedema.

Conditions

Diabetic Macular Oedema

Outcome Measures

Primary Outcomes (1)

• BCVA change from baseline

  Change from baseline in BCVA as measured on The BCVA is measured by Early Treatment Diabetic Retinopathy Study (ETDRS) chart at week 16.

  From Baseline through At Week 16

Secondary Outcomes (6)

• The proportion of patients with an ≥ 2-step DRSS improvement

  At Week 16 and 36

• The proportion of patients with PDR

  The proportion of patients with PDR

• The proportion of new developed PDR

  At Week 16 and 36

• Change from baseline in BCVA over time

  From Baseline through Week 36

• The proportion of patients with CST < 320 μm over time

  From Baseline through Week 36

Study Arms (3)

IBI302 Dose 8mg

EXPERIMENTAL

Drug: IBI302 8mg/eye; Intraocularinjection

Biological: IBI302

Faricimab

ACTIVE COMPARATOR

Drug: Faricimab 6mg/eye; Intraocularinjection

Drug: Faricimab

IBI302 Dose 4mg

EXPERIMENTAL

Drug: IBI302 4mg/eye; Intraocularinjection

Biological: IBI302

Interventions

IBI302 BIOLOGICAL

4 mg IBI302 will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by Pro re nata (PRN) regimen.

IBI302 Dose 4mg

Faricimab DRUG

6 mg faricimab will be administered by intravitreal injection into the study eye once every 4 weeks for 4 consecutive months, followed by PRN regimen.

Faricimab

Eligibility Criteria

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

You may qualify if:

• Informed Consent Form (ICF) must be signed before participating in the study, compliance is good, and willing to complete the visit as planned;
• Subjects aged 18-80 years (inclusive) at the time of screening, and diagnosed with type I or type II diabetes;
• DME involved the macular fovea at screening;
• CST≥320 μm as confirmed by OCT in the study eye at screening.
• At baseline, visual acuity loss in the study eye due to DME with BCVA ranging from 19 to 78 ETDRS letters (inclusive);
• Currently use of insulin, or other injectable drugs, or oral hypoglycemic agents to treat diabetes, HbA1c ≤10% at screening;

You may not qualify if:

• High-risk PDR in the study eye;
• Dense hard exudation that destroyed the fovea structure of the macula in the study eye;
• Iris neovascularization in the study eye;
• Other systemic/ocular disease associated with the study eye may cause subjects fail to respond to study treatment or confuse the interpretation of study findings;
• Uncontrolled glaucoma in the study eye; Eye treatment
• Any previous treatment with IBI302 in the study eye before baseline;
• Intravitreal injection of anti-VEGF or anti-complement agents in the study eye within 90 days prior to baseline;
• Panretinal photocoagulation or macular laser (focal, grid or micropulse) in the study eye within 90 days prior to baseline;
• Cataract surgery was performed in the study eye within 90 days prior to baseline;
• YAG laser capsulotomy or YAG laser peripheral iridotomy were performed in the study eye within 90 days prior to baseline.
• Any other intraocular surgery (eg, corneal transplantation, glaucoma filtration, pars plana vitrectomy, or radiotherapy) Systemic diseases/treatments
• Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable antidiabetic medication \<90 days prior to administration.
• Uncontrolled hypertension.
• Systemic use of anti-VEGF or anti-complement agents within 90 days prior to baseline
• The presence of any other pre-existing disease, metabolic disorder, abnormal results on a physical examination or clinical laboratory examination that may reasonably be suspected of causing contraindications with the investigational drug, or affecting the interpretation of study results, or placing subjects at high risk of treatment complications (e.g., coagulation dysfunction, history of acute cardiovascular and cerebrovascular disease, history of treated or untreated malignancies within the past 5 years, etc.);

Sponsors & Collaborators

• Innovent Biologics Technology Limited (Shanghai R&D Center): lead

Study Sites (1)

Shanghai General hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

MeSH Terms

Interventions

IBI302; faricimab

Central Study Contacts

Yating Liu

CONTACT

86 15821084695; yating.liu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

CN (1)