Diabetic Macular Edema
Conditions
Keywords
DME, EYP-1901, EyePoint
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
Interventions
DRUGEYP-1901
Intravitreal Injection
Intravitreal Injection
Sponsors
EyePoint Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single (Participant)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept | Week 24 | Timing of supplemental injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in best corrected visual acuity (BCVA) | Week 24 | Changes in BCVA |
Countries
United States
Outcome results
None listed