Diabetic Macular Edema, DME, Diabetic Macular Edema (DME)
Conditions
Keywords
EyePoint, Tyrosine Kinase Inhibitor, Diabetic Macular Edema, EYP-1901
Brief summary
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Interventions
DRUGEYP-1901
Intravitreal Injection
Intravitreal Injection
Sponsors
EyePoint Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously treated or treatment naïve patients with a documented diagnosis of macular edema associated with diabetic retinopathy (DR) in the study eye, with onset of disease that began at any time prior to the Screening Visit. * Best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 35 letters (20/200 Snellen equivalent) to 78 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1). * For previously treated participants: at least 1 injection of anti-VEGF in the past 12 months, the most recent anti-VEGF treatment for DME must not have been administered less than 12 weeks prior to the Screening Visit.
Exclusion criteria
* BCVA using ETDRS charts \<30 letters (20/250 Snellen equivalent) in the fellow eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average change in best corrected visual acuity (BCVA) | Weeks 52 and 56 | BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) letter score change from Baseline to the average of Weeks 52 and 56 |
Secondary
| Measure | Time frame |
|---|---|
| Rate of injection burden | Week 56 |
Countries
United States
Contacts
CONTACTRamiro Ribeiro, MD, PhD
Outcome results
None listed