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This study is designed for multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injection of IBI333 in subjects with neovascular age-related macular degeneration (nAMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| :treated with different doses of single intravitreal injections of IBI333 | Experimental | Biological: IBI333 Dose 1 IBI333 of single IVT injections, Biological: IBI333 Dose 2 IBI333 of single IVT injections |
|
| treated with different doses of multiple intravitreal injections of IBI333 | Experimental | Biological: IBI333 Dose 3 IBI333 of multiple IVT injections, Biological: IBI333 Dose 4 IBI333 of multiple IVT injections |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI333 | Biological | Intravitreal injection of IBI333 |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerance indicators |
| Through study completion, a maximum of 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the curve (AUC) of serum concentration of the drug after the administration. | Through study completion, a maximum of 24 weeks | |
| Maximum concentration (Cmax) of the drug after the administration. | Through study completion, a maximum of 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye;
Active ocular or periocular inflammation/infection in either eye;
Prior any treatment of following in the study eye:
Glycated hemoglobin (HbA1c) > 8% within 28 days prior to screening;
Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg);
Systemic administration of steroids within 30 days prior to screening;
Systemic administration of anti-VEGF drugs within 90 days prior to screening;
History of severe hypersensitivity/allergic to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
Participated in any clinical study of any other drug within 90 days prior to enrollment, or attempted to participate in other drug trials during the study;
Other conditions unsuitable for enrollment judged by investigators.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 101199 | China |
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| Time at which maximum concentration (Tmax) occurs for the drug after the administration. | Through study completion, a maximum of 24 weeks |
| The half-life (t1/2) of drug after the administration . | Through study completion, a maximum of 24 weeks |
| Number of participants with anti-drug antibodies or neutralizing antibodies . | Through study completion, a maximum of 24 weeks |
| Changes of BCVA measured by ETDRS chart from baseline. | Through study completion, a maximum of 24 weeks |
| Changes of CST measured by spectral domain optical coherence tomography (SD-OCT) from baseline. | Through study completion, a maximum of 24 weeks |
| Proportion of subjects without intraretinal or subretinal fluid on SD-OCT. | Through study completion, a maximum of 24 weeks |
| Change of height of pigment epithelial detachment from baseline on SD-OCT. | Through study completion, a maximum of 24 weeks |