Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)
VERONA
A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Diabetic Macular Edema (DME)
1 other identifier
interventional
27
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2024
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2023
CompletedFirst Posted
Study publicly available on registry
October 25, 2023
CompletedStudy Start
First participant enrolled
January 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2024
CompletedMarch 4, 2025
September 1, 2024
9 months
October 19, 2023
March 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept
Timing of supplemental injection
Week 24
Secondary Outcomes (1)
Change in best corrected visual acuity (BCVA)
Week 24
Study Arms (3)
EYP-1901 1343 µg
EXPERIMENTALEYP-1901 1343 µg, single dose
EYP-1901 2686 µg
EXPERIMENTALEYP-1901 2686 µg, single dose
Aflibercept
ACTIVE COMPARATORAflibercept 2 mg/0.05mL solution, single dose
Interventions
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
EyePoint Investigative Site
Phoenix, Arizona, 85020, United States
EyePoint Investigative Site
Lemont, Illinois, 60439, United States
EyePoint Investigative Site
Hagerstown, Maryland, 21740, United States
EyePoint Investigative Site
Reno, Nevada, 89502, United States
EyePoint Investigative Site
Erie, Pennsylvania, 16507, United States
EyePoint Investigative Site
Lynchburg, Virginia, 24502, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Ramiro Ribeiro, MD
EyePoint Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single (Participant)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2023
First Posted
October 25, 2023
Study Start
January 15, 2024
Primary Completion
October 24, 2024
Study Completion
October 24, 2024
Last Updated
March 4, 2025
Record last verified: 2024-09