Diabetic Macular OedemaPhase 2NCT06908876
A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）
A Phase 2 study testing IBI302 and Faricimab in people with Diabetic Macular Oedema, run by Innovent Biologics Technology Limited (Shanghai R&D Center) at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Macular Oedema
- What is being tested?
- IBI302 and Faricimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2025to 28 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.);
- Systemic treatment for suspected or active systemic infection (e.g., tuberculosis, hepatitis B, hepatitis C, etc.);
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-maskedblind, Activity-controlled Phase II Clinical Study to Evaluateing the Efficacy and Safety of Intravitreal Injection of IBI302 in Patients With Diabetic Macular Edema（DME） Subjects
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
- Being tested
- IBI302, Faricimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI302Biological
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.
IBI302Biological
8 mg IBI302 will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by PRN regimen.
FaricimabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| IBI302 Dose 8mg | Experimental | Drug: IBI302 8mg/eye; Intraocularinjection Receives: Biological: IBI302 |
| Faricimab | Active comparator | Drug: Faricimab 6mg/eye; Intraocularinjection Receives: Drug: Faricimab |
| IBI302 Dose 4mg | Experimental | Drug: IBI302 4mg/eye; Intraocularinjection Receives: Biological: IBI302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline through At Week 16
Secondary outcomes (6)
The proportion of patients with an ≥ 2-step DRSS improvement
DRSS level is evaluated by color fundus photography (CFP).
Measured: At Week 16 and 36
The proportion of patients with PDR
The presence of PDR is evaluated by CFP.
Measured: The proportion of patients with PDR
The proportion of new developed PDR
The presence of new developed PDR is evaluated by CFP.
Measured: At Week 16 and 36
Change from baseline in BCVA over time
Change from baseline in BCVA as measured on ETDRS chart
Measured: From Baseline through Week 36
The proportion of patients with CST < 320 μm over time
CST is measured by Optical coherence tomography (OCT).
Measured: From Baseline through Week 36
AEs over time
All AEs were recorded and the investigator made an assessment on severity and causality of each AE.
Measured: From Baseline through Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start24 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular OedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics Technology Limited (Shanghai R&D Center)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908876
- Sponsor's protocol ID
- CIBI302B202
- Status last verified
- May 2026
- First submitted
- 27 Mar 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-maskedblind, Activity-controlled Phase II Clinical Study to Evaluateing the Efficacy and Safety of Intravitreal Injection of IBI302 in Patients With Diabetic Macular Edema（DME） Subjects
- ClinicalTrials.gov ID
- NCT06908876
- Acronym / sponsor ID
- CIBI302B202
- Conditions
- Diabetic Macular Oedema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Innovent Biologics Technology Limited (Shanghai R&D Center)Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBI302 Dose 8mg | Experimental | Biological: IBI302Drug: IBI302 8mg/eye; Intraocularinjection |
| Faricimab | Active comparator | Drug: FaricimabDrug: Faricimab 6mg/eye; Intraocularinjection |
| IBI302 Dose 4mg | Experimental | Biological: IBI302Drug: IBI302 4mg/eye; Intraocularinjection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI3024 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. | Biological | IBI302 Dose 4mg |
| IBI3028 mg IBI302 will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by PRN regimen. | Biological | IBI302 Dose 8mg |
| Faricimab6 mg faricimab will be administered by intravitreal injection into the study eye once every 4 weeks for 4 consecutive months, followed by PRN regimen. | Drug | Faricimab |
Primary outcome
BCVA change from baseline
Time frame: From Baseline through At Week 16
Change from baseline in BCVA as measured on The BCVA is measured by Early Treatment Diabetic Retinopathy Study (ETDRS) chart at week 16.
6 secondary outcomes
The proportion of patients with an ≥ 2-step DRSS improvement
Time frame: At Week 16 and 36
The proportion of patients with PDR
Time frame: The proportion of patients with PDR
The proportion of new developed PDR
Time frame: At Week 16 and 36
Change from baseline in BCVA over time
Time frame: From Baseline through Week 36
The proportion of patients with CST < 320 μm over time
Time frame: From Baseline through Week 36
AEs over time
Time frame: From Baseline through Week 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBI302 and Faricimab in people with Diabetic Macular Oedema, run by Innovent Biologics Technology Limited (Shanghai R&D Center) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA change from baseline (time frame: From Baseline through At Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.