Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI302 in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Drug: IBI302 (the first dose level)
* Drug: IBI302 (the second dose level)
* Drug: Aflibercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria Male or female patient ≥ 50 yrs. of age. Active subfoveal or parafoveal CNV secondary to neovascular AMD. Willing and able to sign informed consent form and comply with visit and study procedures per protocol. Exclusion criteria Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment); Presence of active intraocular or periocular inflammation or infection; History of severe hypersensitivity/allergy 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 three months prior to enrollment, or attempted to participate in other drug trials during the study; Diabetic patients have any of the following conditions:HbA1c>7.5% when screening;

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low dose of IBI302<br> | Drug: IBI302 (the first dose level)<br>* q4week (3 injections) followed by PRN dosing<br>|
| Experimental: high dose of IBI302<br> | Drug: IBI302 (the second dose level)<br>* q4week (3 injections) followed by PRN dosing<br>|
| Active Comparator: 2mg aflibercept<br> | Drug: Aflibercept<br>* 2mg, q4week (3 injections) followed by q8week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |