Effect of AIV007 by Periocular Administration in Subjects With nAMD or DME

Study Overview
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Brief Summary
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To determine safety, pharmacokinetics, and duration of effect of periocularly administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).

Official Title
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A Phase 1 Study of the Safety, Pharmacokinetics, and Exploratory Efficacy of Periocular Administration of AIV007 in Subjects With Macular Edema Secondary to Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

Conditions
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Neovascular Age-related Macular Degeneration, Diabetic Macular Edema

Intervention / Treatment
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* Drug: AIV007


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General inclusion Criteria: Male or female subjects aged 21-90 years (inclusive) at screening BCVA in the study eye at screening and baseline/Day 1: ETDRS letter score ≤ 75 and ≥ 24 (20/32 to 20/330 Snellen equivalent) Subject must have received treatment within the 24 months before screening with intravitreal (IVT) injections of an anti-VEGF agent with the last anti-VEGF injection in the study eye being at least 6 weeks (42 days) before baseline/Day 1. Subject has documentation of anti-VEGF responsiveness Subject must provide written informed consent before any study-related procedures are performed Clear ocular media and adequate pupil dilation in both eyes to permit good-quality photographic imaging nAMD subject The active CNV is confirmed by FA (evidence of leakage) Residual intraretinal or subretinal fluid based on SD-OCT CST ≥ 300 µm as assessed by SD-OCT Total lesion size < 10 disc areas (25.4 mm2) Absence of geographic atrophy within 200 µm of the fovea If subretinal hemorrhage is present, it must be < 50% of the total CNV lesion and/or not involve the fovea If fibrosis is present, it must be <50% of the total lesion area DME subject Diagnosis of diabetes mellitus (Type 1 or Type 2) Subject has clinically significant DME with central involvement (CST≥300 μm by OCT) The decrease in vision in the study eye was determined by the investigator to be primarily the result of DME Exclusion Criteria: Previous treatment for nAMD or DME in the study eye other than standard-of-care anti-VEGF IVT injection, e.g., cell therapy, brachytherapy, gene therapy Uncontrolled IOP, defined as an IOP > 25 mmHg Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) >10% at screening visit The spherical equivalent for refractive error in the study eye of worse than 8.0 diopters of myopia (before cataract or refractive surgery) per the current prescription Any history of active bacterial, viral, fungal, or parasitic ocular or periocular infection, or intraocular inflammation in either eye within the 30 days before the screening Visit History of vitreous hemorrhage within 3 months before screening in the study eye Uncontrolled systemic disease or any other condition or therapy that would make the participant unsuitable for the study Participation in any investigational study within 60 days before the screening visit, or planned use of an investigational product or device during the study; any exposure to a prior investigational drug product must be fully washed out (at least 5 half-lives) History of allergy or hypersensitivity to constituents of the study treatment formulation, topical iodine, ocular antimicrobial solutions, or clinically relevant hypersensitivity to fluorescein

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 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 Dose 1<br>Periocular injection, Dose 1 | Drug: AIV007<br>* Periocular injection<br>|
| Experimental: AIV007 Dose 2<br>Periocular injection, Dose 2 | Drug: AIV007<br>* Periocular injection<br>|
| Experimental: AIV007 Dose 3<br>Periocular injection, Dose 3 | Drug: AIV007<br>* Periocular injection<br>|
| Experimental: AIV007 Dose 4<br>Periocular injection, Dose 4 | Drug: AIV007<br>* Periocular injection<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 and serious adverse events | Approximately 168 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in best-corrected visual acuity (BCVA) | Number of Early Treatment Diabetic Retinopathy Study (ETDRS) letters | Approximately 168 days | 
| Mean change from baseline in central subfield thickness as measured by spectral domain optical coherence tomography (SD-OCT) | SD-OCT read by a central reading center | Approximately 168 days | 
| Mean time to rescue medication | number of days to receive rescue medication | Approximately 168 days |