Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-10-24

Brief Summary

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A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept

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Detailed Description

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A study to evaluate Efficacy and Safety of two doses of EYP-1901 in subjects with DME

Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Single (Participant)

Study Groups

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EYP-1901 1343 µg

EYP-1901 1343 µg, single dose

Group Type EXPERIMENTAL

EYP-1901

Intervention Type DRUG

Intravitreal Injection

EYP-1901 2686 µg

EYP-1901 2686 µg, single dose

Group Type EXPERIMENTAL

EYP-1901

Intervention Type DRUG

Intravitreal Injection

Aflibercept

Aflibercept 2 mg/0.05mL solution, single dose

Group Type ACTIVE_COMPARATOR

Aflibercept 2Mg/0.05Ml Inj,Oph

Intervention Type DRUG

Intravitreal Injection

Interventions

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EYP-1901

Intravitreal Injection

Intervention Type DRUG

Aflibercept 2Mg/0.05Ml Inj,Oph

Intravitreal Injection

Intervention Type DRUG

Other Intervention Names

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Vorolanib Eylea

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No