Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)
Phase 2
Completed
- Conditions
- Diabetic Macular Edema
- Interventions
- Registration Number
- NCT06099184
- Lead Sponsor
- EyePoint Pharmaceuticals, Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- 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 Criteria
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aflibercept Aflibercept 2Mg/0.05Ml Inj,Oph Aflibercept 2 mg/0.05mL solution, single dose EYP-1901 2686 µg EYP-1901 EYP-1901 2686 µg, single dose EYP-1901 1343 µg EYP-1901 EYP-1901 1343 µg, single dose
- Primary Outcome Measures
Name Time Method Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept Week 24 Timing of supplemental injection
- Secondary Outcome Measures
Name Time Method Change in best corrected visual acuity (BCVA) Week 24 Changes in BCVA
Trial Locations
- Locations (1)
EyePoint Investigative Site
🇺🇸Lynchburg, Virginia, United States