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This open-label study is being conducted to evaluate the initial safety and tolerability of BBC1501 IVT in patients with nAMD. The primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of IVT BBC1501 in patients with nAMD. The secondary objective of this study is to exploratory of BBC1501 efficacy following 3 ascending dose of BBC1501 in nAMD patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBC1501 1.25ug | Experimental | Cohort 1; open-label, non-randomized, single administration |
|
| BBC1501 2.5ug | Experimental | Cohort 2; open-label, non-randomized, single administration |
|
| BBC1501 5ug | Experimental | Cohort 3; open-label, non-randomized, single administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBC1501 | Drug | BBC1501 solution for Intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of ophthalmic and systemic TEAEs, during study period | To evaluate the safety and tolerability of a single IVT dose of BBC1501 at 4 weeks after dose.To characterize ocular and non-ocular safety by the incidence of treatment-emergent adverse events (AEs) (new or worsening from baseline) summarized categorically by system organ class and/or preferred term. | Every week up to 4 weeks |
| Assessment of ophthalmic and systemic TEAEs, during study period | To evaluate the safety and tolerability of a single IVT dose of BBC1501 at 12 weeks after dose.To characterize ocular and non-ocular safety by the incidence of treatment-emergent adverse events (AEs) (new or worsening from baseline) summarized categorically by system organ class and/or preferred term. | every 4 weeks up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline | Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT) | Baseline, Week4 |
| Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CNV size according to fluorescein angiogram | Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA) | Baseline, Week4 |
| Change in CNV size according to fluorescein angiogram |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jihye choe | Contact | +827046675278 | jihye.choe@benobio.com |
| Name | Affiliation | Role |
|---|---|---|
| Inhyun Lee, ph.D | Benobio Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benobio Investigational site | Not yet recruiting | Sydney | New South Wales | 2000 | Australia |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT) |
| Baseline, Week12 |
| Number of patients who initiation of rescue therapy during study | Exploratory using rescue therapy during study and follow-up period | Week1, Week12 |
Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)
| Baseline, Week12 |
| Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume | Assessment Central retinal thickness from baseline by Spectral Domain Optical Coherence Tomography (SD-OCT) | Baseline, Week4 |
| Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume | Assessment Central retinal thickness from baseline by Spectral Domain Optical Coherence Tomography (SD-OCT) | Baseline, Week12 |
| Sydney Hospital | Recruiting | Sydney | Australia |