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This is a multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IBI302 in subjects with neovascular age-related macular degeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 IBI302 treated with high dose level of IBI302 | Experimental | Drug: IBI302 4mg/eye;Intraocular injection |
|
| Aflibercept | Active Comparator | Drug: Aflibercept 2mg/eye;Intraocular injection |
|
| cohort 1 IBI302 treated with low dose level of IBI302 | Experimental | Drug: IBI302 2mg/eye;Intraocular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose IBI302 | Biological | Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The visual efficacy of IBI302 | Baseline to week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| other visual effects of IBI302 | the proportion if BCVA improvement ≥0,5,10 or 15 letters at week 12, 28, 36 and 52. | Baseline to week 52 |
| the anatomical effects of IBI302 on OCT | the mean change of central subfield thickness from BL to week 52 at week 12, 28, 36 and 52 |
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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;
Presence of uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg despite the standardized treatment);
Presence of active intraocular or periocular inflammation or infection;
Prior any treatment of following in the study eye:
Presence of any systemic disease: including but not limited toactive infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor;
History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
Participated in any clinical study of any other drug within three months 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 |
|---|---|---|---|---|---|---|
| Innovent Biologics (Suzhou) Co,Ltd. | Suzhou | Jiangsu | 215123 | China |
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| ID | Term |
|---|---|
| C000620229 | IBI302 |
| C533178 | aflibercept |
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| High dose IBI302 | Biological | High dose IBI302 intravitreal injection given as every other month after three loading monthly injection |
|
| Aflibercept | Drug | Intraocular injection |
|
| Baseline to week 52 |
| the anatomical effects of IBI302 on FFA | the change of CNV area, CNV leakage area, total lesion area from BL to week 36 or 52 | Baseline to week 52 |
| the safety of IBI302 | the incidence of ocular AE or any systemic AE, TEAE, SAE | Baseline to week 52 |
| Immunogenicity of IBI302 | the positive rate of anti-drug antibody and neutralizing antibody | Baseline to week 52 |