Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed for single-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single intravitreal injection of IBI302 in patients with wet AMD.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 IBI302 treated with first dose level of IBI302 | Experimental |
| |
| cohort 2 IBI302 treated with second dose level of IBI302 | Experimental |
| |
| cohort 3 IBI302 treated with third dose level of IBI302 | Experimental |
| |
| cohort 4 IBI302 treated with fourth dose level of IBI302 | Experimental |
| |
| cohort 5 IBI302 treated with fifth dose level of IBI302 | Experimental |
| |
| cohort 6 IBI302 treated with sixth dose level of IBI302 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI302 | Drug | 0.05mg/eye;Intraocular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation indicators | Decreasing of BCVA; b) Changes in intraocular pressure compared with baseline; c) Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events; | Baseline to Day43 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy evaluation indicators | Changes in central subfield thickness by OCT compared with baseline; b) Changes in CNV area by FA compared with baseline; c) Changes in BCVA compared with baseline. | Baseline to Day43 |
| Immunogenicity evaluation indicators |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Presence of other causes of CNV other than wet AMD in the study eye.
Presence of active diabetic retinopathy in the study eye.
Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment).
Prior retinal detachment in the study eye.
Prior any treatment of following in the study eye:
Presence of any non-AMD disease that may affect visual acuity in the study eye
Prior anti-VEGF therapy within 1 month before study drug administration or plan of above anti-VEGF therapy in the non-study eye during the whole study.
Oral steroid drugs within 1 month before study drug administration.
Presence of active intraocular or periocular inflammation or infection.
Diabetic patients have any of the following conditions:
Hypertension (defined as systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg despite standard treatment);
Presence of any following laboratory abnormality:
Large or medium surgery, or unhealed surgical incisions, ulcers or fractures within 1 month before study drug administration.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35648811 | Derived | Yang S, Li T, Jia H, Gao M, Li Y, Wan X, Huang Z, Li M, Zhai Y, Li X, Yang X, Wang T, Liang J, Gu Q, Luo X, Qian L, Lu S, Liu J, Song Y, Wang F, Sun X, Yu D. Targeting C3b/C4b and VEGF with a bispecific fusion protein optimized for neovascular age-related macular degeneration therapy. Sci Transl Med. 2022 Jun;14(647):eabj2177. doi: 10.1126/scitranslmed.abj2177. Epub 2022 Jun 1. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000620229 | IBI302 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| IBI302 |
| Drug |
0.15mg/eye;Intraocular injection |
|
| IBI302 | Drug | 0.5mg/eye;Intraocular injection |
|
| IBI302 | Drug | 1mg/eye;Intraocular injection |
|
| IBI302 | Drug | 2mg/eye;Intraocular injection |
|
| IBI302 | Drug | 4mg/eye;Intraocular injection |
|
Positive rate of anti-drug antibody and neutralizing antibody |
| Baseline to Day43 |
| The area under the drug-time curve from 0 to time t (AUC0-t) | Baseline to Day43 |
| The area under the curve at the time of 0-infinity (AUC0-∞) | Baseline to Day43 |
| The peak concentration (Cmax) | Baseline to Day43 |
| The peak time (Tmax) | Baseline to Day43 |
| Clearance rate (CL) | Baseline to Day43 |
| Half-life (t1/2) | Baseline to Day43 |
| Free and total VEGF concentration | Baseline to Day43 |