Diabetic Macular EdemaPhase 1NCT05489718
A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema
A Phase 1 study testing IBI324 in people with Diabetic Macular Edema, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- IBI324
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 5 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
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- 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;
- 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;
- History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
- Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
- 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;
- Other conditions unsuitable for enrollment judged by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Diabetic Macular Edema
- Being tested
- IBI324
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI324Biological
Dose 2 IBI324 of multiple IVT injection
IBI324Biological
Dose 2 IBI324 of single IVT injection
IBI324Biological
Dose 1 IBI324 of single IVT injection
IBI324Biological
Dose 3 IBI324 of single IVT injection
IBI324Biological
Dose 3 IBI324 of multiple IVT injection
| Study group | Role | What they receive |
|---|---|---|
| treated with different doses of single intravitreal inmection of IBI324 | Experimental | Not described Receives: Biological: IBI324 |
| treated with different doses of multiple intravitreal inmection of IBI324 | Experimental | Not described Receives: Biological: IBI324 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, a maximum of 24 weeks
Secondary outcomes (5)
The incidence of adverse events
Measured: Through study completion, a maximum of 24 weeks
Changes in visual acuity as measured by BCVA compared with baseline
Measured: 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
Measured: 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
Measured: Through study completion, a maximum of 24 weeks
Immunogenicity evaluation indicators
Positive rate of anti-drug antibody
Measured: Through study completion, a maximum of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Aug 2022
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489718
- Sponsor's protocol ID
- CIBI324A101
- Status last verified
- Oct 2023
- First submitted
- 21 Jun 2022
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41494748
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI324 in Subjects With Diabetic Macular Edema(DME)
- ClinicalTrials.gov ID
- NCT05489718
- Acronym / sponsor ID
- CIBI324A101
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 5 Aug 2022 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
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 |
|---|---|---|
| IBI324Dose 2 IBI324 of multiple IVT injection | Biological | treated with different doses of multiple intravitreal inmection of IBI324 |
| IBI324Dose 2 IBI324 of single IVT injection | Biological | treated with different doses of single intravitreal inmection of IBI324 |
| IBI324Dose 1 IBI324 of single IVT injection | Biological | treated with different doses of single intravitreal inmection of IBI324 |
| IBI324Dose 3 IBI324 of single IVT injection | Biological | treated with different doses of single intravitreal inmection of IBI324 |
| IBI324Dose 3 IBI324 of multiple IVT injection | Biological | treated with different doses of multiple intravitreal inmection of IBI324 |
Primary outcome
Safety evaluation indicators
Time frame: Through study completion, a maximum of 24 weeks
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
5 secondary outcomes
The incidence of adverse events
Time frame: Through study completion, a maximum of 24 weeks
Changes in visual acuity as measured by BCVA compared with baseline
Time frame: 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
Time frame: Through study completion, a maximum of 24 week
Pharmacokinetic (PK) profiles, such as half-life time (t1/2)，etc
Time frame: Through study completion, a maximum of 24 weeks
Immunogenicity evaluation indicators
Time frame: Through study completion, a maximum of 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Derived from this study: PubMed 41494748Wang 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.
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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 1 study testing IBI324 in people with Diabetic Macular Edema, run by Innovent Biologics (Suzhou) Co. Ltd. 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 7 inclusion and 20 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: finished, as of the sponsor's last update on 27 Oct 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety evaluation indicators (time frame: Through study completion, a maximum of 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05489718, which also lists 1 linked publication.
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 Oct 2023.