Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)
Completed · Phase 2
Conditions studied: Diabetic Macular Edema
In brief
A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept
Key facts
- Study ID
- NCT06099184
- Run by
- EyePoint Pharmaceuticals, Inc.
- People needed
- 27
- Starts
- 2024-01-15
- Expected to finish
- 2024-10-24
- Last updated by the study team
- 2025-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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).
Where it is running
- EyePoint Investigative Site — Phoenix, Arizona, United States
- EyePoint Investigative Site — Lemont, Illinois, United States
- EyePoint Investigative Site — Hagerstown, Maryland, United States
- EyePoint Investigative Site — Reno, Nevada, United States
- EyePoint Investigative Site — Erie, Pennsylvania, United States
- EyePoint Investigative Site — Lynchburg, Virginia, United States
Full record on ClinicalTrials.gov
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