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This study is designed for multi-center, open-label, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose of IBI302 | Experimental |
| |
| high dose of IBI302 | Experimental |
| |
| 2mg aflibercept | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI302 (the first dose level) | Drug | q4week (3 injections) followed by PRN dosing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography | Baseline to Day140 | |
| Incidence of adverse events | Baseline to Day140 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in central subfield thickness by OCT compared with baseline | Baseline to Day140 | |
| Changes in CNV characteristics and CNV area by FA compared with baseline | Baseline to Day140 | |
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Inclusion Criteria:
Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36410472 | Derived | Jia H, Li T, Sun J, Gong Y, Liu H, Wang H, Chen J, Liu W, Lu S, Feng L, Wan Q, Qian L, Wang F, Liu X, Sun X. A Novel Bispecific Fusion Protein Targeting C3b/C4b and VEGF in Patients With nAMD: A Randomized, Open-Label, Phase 1b Study. Am J Ophthalmol. 2023 Apr;248:8-15. doi: 10.1016/j.ajo.2022.11.016. Epub 2022 Nov 21. |
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| IBI302 (the second dose level) |
| Drug |
q4week (3 injections) followed by PRN dosing |
|
| Aflibercept | Drug | 2mg, q4week (3 injections) followed by q8week |
|
| Changes in BCVA compared with baseline |
| Baseline to Day140 |
| Positive rate of anti-drug antibody and neutralizing antibody of IBI302 | Baseline to Day140 |
| the area under the drug-time curve from 0 to time t of IBI302 | Baseline to Day140 |
| the area under the curve at the time of 0-infinity of IBI302 | Baseline to Day140 |
| The peak concentration of IBI302 | Baseline to Day140 |
| The peak time of IBI302 | Baseline to Day140 |
| Clearance rate of IBI302 | Baseline to Day140 |
| Half-life of IBI302 | Baseline to Day140 |
| VEGF concentration | Baseline to Day140 |
| Concentration of complement fragments | Baseline to Day140 |
| ID | Term |
|---|---|
| C000620229 | IBI302 |
| C533178 | aflibercept |
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