Status:
COMPLETED
Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)
Lead Sponsor:
EyePoint Pharmaceuticals, Inc.
Conditions:
Nonproliferative Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A prospective, randomized, double-masked study that evaluated the ocular efficacy and safety of two doses of the EYP-1901 intravitreal (IVT) insert compared to sham.
Detailed Description
This study evaluated the ocular efficacy and safety of two doses of the EYP-1901 IVT insert compared to sham using a randomized double-masked trial design.
Eligibility Criteria
Inclusion
- Participants must have a hemoglobin A1c \<=12%
- Study eye with moderately severe to severe Non proliferative Diabetic Retinopathy (NPDR) (based on the Diabetic Retinopathy Severity Scale (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
- 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 (PRP) in the study eye in the last 12 months.
Key Trial Info
Start Date :
September 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2024
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT05383209
Start Date
September 28 2022
End Date
May 6 2024
Last Update
August 15 2025
Active Locations (36)
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1
EyePoint Investigative Site
Phoenix, Arizona, United States, 85020
2
EyePoint Investigative Site
Huntington Beach, California, United States, 92647
3
EyePoint Investigative Site
Oxnard, California, United States, 93036
4
EyePoint Investigative Site
Palm Desert, California, United States, 92211