Effect of Intravitreally Administered AIV007 in Subjects With nAMD

Study Overview
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Brief Summary
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To determine safety, pharmacokinetics, and duration of effect of intravitreally administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration

Official Title
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A Phase I Study of the Safety, Pharmacokinetics, and Duration of Effect of Intravitreally Administered AIV007 Gel Suspension in Subjects With Neovascular Age-Related Macular Degeneration

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Drug: AIV007


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged ≥ 50 years Subjects must provide written informed consent before any study-related procedures are performed Active subfoveal CNV in the study eye secondary to AMD that has previously been treated with at least 3 intravitreal injections of an anti-VEGF agent BCVA in the study eye Sentinel subjects only: 65 ETDRS letters (20/50 Snellen equivalent) or worse All other subjects: 78 to 35 ETDRS letters (20/32 to 20/200 Snellen equivalent) Clear ocular media and adequate pupil dilation in both eyes to permit good quality photographic imaging Exclusion Criteria: Previous treatment for nAMD in the study eye, other than standard-of-care anti- VEGF IVT injection, eg, cell therapy, brachytherapy, gene therapy Treatment with anti-VEGF in the non-study eye 2 weeks prior to baseline Presence of diabetic retinopathy or glaucoma in either eye Spherical equivalent for refractive error in the study eye of worse than 8.0 diopters of myopia (prior to cataract or refractive surgery) Presence of active infection or inflammation within 30 days prior to screening Presence of contraindications to anti-VEGF treatment, including myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke within the last 3 months of baseline Uncontrolled hypertension or diabetes mellitus

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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIV007 Treatment Dose 1<br>Intravitreal, Dose 1 | Drug: AIV007<br>* intravitreal<br>|
| Experimental: AIV007 Treatment Dose 2<br>Intravitreal, Dose 2 | Drug: AIV007<br>* intravitreal<br>|
| Experimental: AIV007 Treatment Dose 3<br>Intravitreal, Dose 3 | Drug: AIV007<br>* intravitreal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Incidence of adverse events | approximately 224 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in BCVA | Number of ETDRS letters | approximately 224 days | 
| Mean change from baseline in central subfield thickness as measured by optical coherence tomography | OCT read by a central reading center | approximately 224 days | 
| Mean time to escape medication |  | approximately 224 days |