Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)

Study Overview
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Brief Summary
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A prospective, randomized, double-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to sham

Official Title
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A Phase 2, Multicenter, Prospective, Double-masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Sham for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)

Conditions
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Nonproliferative Diabetic Retinopathy

Intervention / Treatment
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* Drug: EYP-1901
* Other: Sham IVT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have a hemoglobin A1c ≤12% Study eye with moderately severe to severe NPDR (based on the DRSS levels 47 or 53) Best corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better). Exclusion Criteria: Presence of any active Center involved-diabetic macular edema in the study eye as determined by the Investigator on clinical examination, or within the central subfield thickness (CST) of the study eye, with a CST threshold greater than 320 microns. Any evidence or documented history of prior focal or grid laser photocoagulation or any pan-retinal photocoagulation in the study eye in the last 12 months.

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EYP-1901 2060 ug<br>EYP-1901 2060 ug; single injection | Drug: EYP-1901<br>* Intravitreal Injection<br>|
| Experimental: EYP-1901 3090 ug<br>EYP-1901 3090 ug; single injection | Drug: EYP-1901<br>* Intravitreal Injection<br>|
| Sham Comparator: Sham IVT<br>Sham IVT; single injection | Other: Sham IVT<br>* Sham IVT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects improving ≥2 steps in the Diabetic Retinopathy Severity Scale (DRSS) score each EYP-1901 dose level versus the sham IVT injection group. |  | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects improving ≥2 steps in the DRSS score in each dose level vs. sham |  | Baseline, Week 48, Week 96 | 
| Percentage of subjects who developed a vision-threatening complication due to diabetic retinopathy |  | Week 24, Week 48, Week 96 | 
| Rates of ocular (study eye and fellow eye) and non-ocular Treatment-Emergent Adverse Events |  | Week 24, Week 48, Week 96 | 

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