A Study of IBI302 in Patients With nAMD

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-center, Randomized, Double-blind, Active-controlled Phase II Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Neovascular Age-related Macular Degeneration

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Biological: Low dose IBI302
* Biological: High dose IBI302
* Drug: Aflibercept


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Male or female patient ≥ 50 yrs. of age. Active subfoveal or parafoveal CNV secondary to neovascular AMD. BCVA score of 24-73 letters using ETDRS charts in the study eye. Willing and able to sign informed consent form and comply with visit and study procedures per protocol. 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: Anti-VEGF therapy or anti-complement therapy within 3 months prior to screening; Laser photocoagulation within 3 months prior to screening; Photodynamic therapy or vitreoretinal surgery; Intraocular glucocorticoid injection within 6 months prior to enrollment; 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cohort 1 IBI302 treated with high dose level of IBI302<br>Drug: IBI302 4mg/eye;Intraocular injection | Biological: High dose IBI302<br>* High dose IBI302 intravitreal injection given as every other month after three loading monthly injection<br>|
| Active Comparator: Aflibercept<br>Drug: Aflibercept 2mg/eye;Intraocular injection | Drug: Aflibercept<br>* Intraocular injection<br>|
| Experimental: cohort 1 IBI302 treated with low dose level of IBI302<br>Drug: IBI302 2mg/eye;Intraocular injection | Biological: Low dose IBI302<br>* Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The visual efficacy of IBI302 |  | Baseline to week 36 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |