NCT06099184
Completed
Phase 2
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)
ConditionsDiabetic Macular Edema
Overview
- Phase
- Phase 2
- Intervention
- EYP-1901
- Conditions
- Diabetic Macular Edema
- Sponsor
- EyePoint Pharmaceuticals, Inc.
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
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).
Arms & Interventions
EYP-1901 1343 µg
EYP-1901 1343 µg, single dose
Intervention: EYP-1901
EYP-1901 2686 µg
EYP-1901 2686 µg, single dose
Intervention: EYP-1901
Aflibercept
Aflibercept 2 mg/0.05mL solution, single dose
Intervention: Aflibercept 2Mg/0.05Ml Inj,Oph
Outcomes
Primary Outcomes
Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept
Time Frame: Week 24
Timing of supplemental injection
Secondary Outcomes
- Change in best corrected visual acuity (BCVA)(Week 24)
Study Sites (1)
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Related News
EyePoint's Duravyu Shows Promise in Phase 2 Trial for Diabetic Macular Edema- EyePoint Pharmaceuticals' Duravyu demonstrated significant improvement in visual acuity and retinal thickness in patients with diabetic macular edema (DME).
- The Phase 2 VERONA trial showed Duravyu 2.7mg led to an 8.9-letter improvement in BCVA compared to a 3.2-letter improvement with aflibercept at 16 weeks.
- Duravyu exhibited a favorable safety profile with no Duravyu-related serious adverse events and a reduced need for supplemental aflibercept injections.
- These results support Duravyu's potential as a sustained-release therapy for DME, offering a less burdensome treatment option for patients.EyePoint's Duravyu Shows Promise in Phase 2 Trial for Diabetic Macular Edema- EyePoint Pharmaceuticals' Duravyu demonstrated early and sustained improvement in visual acuity and anatomical control in DME patients compared to aflibercept.
- The VERONA trial's 16-week interim results showed an 8.9-letter improvement in BCVA with Duravyu 2.7mg versus 3.2 letters with aflibercept.
- Duravyu exhibited a favorable safety profile with no Duravyu-related serious adverse events and a higher percentage of supplement-free eyes at 16 weeks.
- These results support Duravyu's potential as a durable treatment option for DME, with pivotal trials underway for wet AMD as well.