Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)
A prospective, randomized, double-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to sham
|Condition or Disease||Intervention/Treatment||Phase|
Arms and Interventions
|Experimental: EYP-1901 2060 ug
EYP-1901 2060 ug; single injection
|Experimental: EYP-1901 3090 ug
EYP-1901 3090 ug; single injection
|Sham Comparator: Sham IVT
Sham IVT; single injection
Other: Sham IVT
Primary Outcome Measures
- 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
- 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]
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).
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.
Contacts and Locations
LocationsNo locations specified.
Sponsors and Collaborators
- EyePoint Pharmaceuticals, Inc.
Study Documents (Full-Text)None provided.