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The study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept | Active Comparator | Drug: Aflibercept 2mg/eye; Intraocular injection |
|
| IBI302 dose 8mg | Experimental | Drug: IBI302 8mg/eye; Intraocular injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept Ophthalmic | Drug | 2mg Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive monthes, folloesd by once every 8 weeks(Q8W). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in Best corrected visual acuity ( BCVA ) in the study eye. | Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at week 44, 48, 52. | At week 44, 48, 52 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants with absence intraretinal fluid (IRF) and absence subretinal fluid (SRF) in the fovea at Week 16 | The intraretinal fluid and subretinal fluid is measured by optical coherence tomography (OCT) in the central subfield(center 1 millimeter) | At week 16 |
| Change from baseline in BCVA at Week 52 and 100 |
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Inclusion Criteria:
Exclusion Criteria:
Ocular disease:
Ocular treatment:
General condition or treatment:
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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 |
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| IBI302 | Biological | 8 mg IBI302 will be administered by intraitreal injection into the study eye at intervals as specified in the study protocol. |
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Best corrected visual acuity (BCVA) was measured on early treatment diabetic retinopathy study(ETDRS) chart at a starting distance of 4 meters. The BCVAletter score ranges from 0 to 100(best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. |
| Upto Week 100 |
| Change from baseline in central subfield thickness (CST) measured by optical coherence tomography (OCT) at Week 52 and 100 | Central subfield thickness was defined as the distance between the internal limiting member and the Bruch's member using OCT, as assessed by the central reading center. | Upto Week 100 |
| Change from baseline in area of CNV on fundus fluorescence angiography (FFA) at Week 52 and 100 | the area of the choroidal neovascularization lesion in the study eye was measured by a central reading center using FFA | Upto Week 100 |
| Proportion of participants on a q8W, q12W, and q16W treatment intervals at Week 52 and 100 | Percentages are based on number of participants randomized to the IBI302 group who have not discontinued the study at week 52 and 100. the treatment interval at a givven visit is defined as the treatment interval decision followed at that visit. | Upto Week 100 |
| Incidence, relatedness to the study drug and severity of ocular and Non-ocular adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE). | All AEs were recorded and the investigator made an assessment of seriousness,severity, and causality of each AE. | Upto Week 100 |