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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI302 Dose 8mg | Experimental | Drug: IBI302 8mg/eye; Intraocularinjection |
|
| Faricimab | Active Comparator | Drug: Faricimab 6mg/eye; Intraocularinjection |
|
| IBI302 Dose 4mg | Experimental | Drug: IBI302 4mg/eye; Intraocularinjection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with an ≥ 2-step DRSS improvement | DRSS level is evaluated by color fundus photography (CFP). | At Week 16 and 36 |
| The proportion of patients with PDR | The presence of PDR is evaluated by CFP. |
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Inclusion criteria:
Exclusion criteria: Eye disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General hospital | Shanghai | Shanghai Municipality | 200080 | China |
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| ID | Term |
|---|---|
| C000620229 | IBI302 |
| C000723200 | faricimab |
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| IBI302 | Biological | 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. |
|
| 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. |
|
| The proportion of patients with PDR |
| The proportion of new developed PDR | The presence of new developed PDR is evaluated by CFP. | At Week 16 and 36 |
| Change from baseline in BCVA over time | Change from baseline in BCVA as measured on ETDRS chart | From Baseline through Week 36 |
| The proportion of patients with CST < 320 μm over time | CST is measured by Optical coherence tomography (OCT). | 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. | From Baseline through Week 36 |