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This study is designed for Open-label, multi-center, single-arm Phase II trail to evaluate the efficacy and safety of intravitreal injection of IBI302 in nAMD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI302 8mg dose 8mg | Experimental | Drug: IBI302 8mg/Intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI302 8mg dose | Drug | 8 mg IBI302 will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants whose best corrected visual acuity (BCVA) of the study eye decreased by less than 15 letters from baseline as measured by the visual acuity chart in the early treatment diabetic retinopathy study (ETDRS) at week 52 | Week52 |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in BCVA from baseline at each visit | Baseline,Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | |
| Proportion of patients with BCVA improvement of ≥0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52 | Week52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yating Liu | Contact | 86 15821084695 | yating.liu@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai general hospital | Recruiting | Shanghai | Shanghai Municipality | P. R. China 200080 | China |
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| ID | Term |
|---|---|
| C000620229 | IBI302 |
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| Proportion of participants with a decrease in BCVA of >0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52 | Week52 |
| The change in central subfield thickness of the macula measured by OCT from the baseline at week 52 | Week52 |
| Proportion of participants with IRF/SRF/Pigment epithelial detachment (PED) on OCT at Week 52 | Week52 |
| Change in choroidal neovascularization (CNV) area on fundus fluorescein angiography (FFA) at week 52 compared to baseline | Week52 |
| Change in CNV leakage area on FFA at week 52 compared to baseline | Week52 |
| Proportion of participants with new-onset MA on OCT at Week 52 | Week52 |
| Proportion of new-onset fibrosis on color fundus photography (CFP) at Week 52 | Week52 |
| Change in MA area on OCT from baseline at Week 52 | Week52 |
| Change in fibrosis area and maximum lesion diameter on CFP from baseline at Week 52 | Week52 |
| The incidence rate, correlation with the studied drugs, and severity of ocular and systemic adverse events (AE), treatment emergent adverse events (TEAE), and serious adverse events (SAE) | From baseline through Week 52 |
| The production of anti-drug antibodies in the serum | Day0、Week4、Week16、Week32、Week48、Week52 |