First in Human Study to Evaluate the Safety and Tolerability of EYP-1901 in Patients With Wet Age Related Macular Degeneration (wAMD)

Study Overview
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Brief Summary
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Phase 1 open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of a single dose injections of EYP-1901 at three dose levels: 440 µg, 2060 µg and 3090 µg in subjects with Wet Age Related Macular Degeneration (wAMD)

Official Title
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A Phase 1, Multicenter, Prospective, Open-Label, Dose Escalation Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), in Subjects With Wet AMD

Conditions
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Wet Age-related Macular Degeneration

Intervention / Treatment
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* Drug: EYP-1901


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects diagnosed with wet Age-Related Macular Degeneration (wAMD), in the study eye. Subject must have received ≥3 prior injections with the same anti-VEGF product: bevacizumab, ranibizumab, or aflibercept) in the 6 months prior to the Screening Visit, in the study eye. Demonstrated response to the intravitreal anti-vascular endothelial growth factor (VEGF) treatment in the study eye. Best-corrected visual acuity (BCVA) using ETDRS charts of 25 letters (20/320 Snellen equivalent) to 85 letters (20/20 Snellen equivalent). Exclusion Criteria: History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye. Subfoveal fibrosis or scarring >50% of the total lesion, or atrophy in the study eye, confirmed by central reading center. Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia that would compromise vision in the study eye, confirmed by central reading center. Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of the study results. Active intraocular inflammation (grade trace or above) in the study eye. History of rhegmatogenous retinal detachment or treatment for retinal detachment or macular hole (stage 3 or 4) in the study eye. History of idiopathic or autoimmune-associated uveitis in either eye. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye. History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye.

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: 440 ug, single dose<br>EYP-1901 440 ug, single dose | Drug: EYP-1901<br>* Intravitreal injection<br>|
| Experimental: 2060 ug, single dose<br>EYP-1901 2060 ug, single dose | Drug: EYP-1901<br>* Intravitreal injection<br>|
| Experimental: 3090 ug, single dose<br>EYP-1901 3090 ug, single dose | Drug: EYP-1901<br>* Intravitreal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs) | Number of ocular (study eye) and systemic TEAEs during the treatment period - Intent-to-Treat (ITT) Population | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in best corrected visual acuity (BCVA) by EDTRS | Mean change from Baseline in BCVA in the Study Eye | Baseline, Week 48 | 
| Mean change in central subfield thickness (CST) | Mean change from Baseline in CST measured in microns by Spectral-domain - optical coherence tomography (OCT) assessments by a study-certified OCT technician in the study eye | Baseline, Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wAMD, EYP-1901, EyePoint, DAVIO