Status:
COMPLETED
Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)
Lead Sponsor:
EyePoint Pharmaceuticals, Inc.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept
Detailed Description
A study to evaluate Efficacy and Safety of two doses of EYP-1901 in subjects with DME
Eligibility Criteria
Inclusion
- Diagnosis of diabetes mellitus in the study eye, with disease onset any time prior to the Screening Visit
- Previously treated with at least 1 intravitreal anti-VEGF in the last 6 months in the study eye at least 8 weeks prior to the Screening Visit.
- BCVA letter score of 35 letters (20/200 Snellen equivalent) to 75 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).
Exclusion
- Any current or history of ocular disease other than DME
- BCVA using ETDRS charts \<30 letters (20/250 Snellen equivalent) in the fellow eye.
- Active ocular inflammation or active infection in either eye at Baseline (Day 1).
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06099184
Start Date
January 15 2024
End Date
October 24 2024
Last Update
March 4 2025
Active Locations (6)
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1
EyePoint Investigative Site
Phoenix, Arizona, United States, 85020
2
EyePoint Investigative Site
Lemont, Illinois, United States, 60439
3
EyePoint Investigative Site
Hagerstown, Maryland, United States, 21740
4
EyePoint Investigative Site
Reno, Nevada, United States, 89502