Study of EYP-1901 in Patients With Diabetic Macular Edema... | NCT06099184

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

NCT06099184

Sponsor

EyePoint Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Mar 4, 2025Actual

Enrollment

27Actual

Phase

Phase 2

Conditions

Diabetic Macular Edema

Interventions

EYP-1901
Aflibercept 2Mg/0.05Ml Inj,Oph

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2024Actual

Primary Completion Date

Oct 24, 2024Actual

Completion Date

Oct 24, 2024Actual

First Submitted Date

Oct 19, 2023

First Submission Date that Met QC Criteria

Oct 19, 2023

First Posted Date

Oct 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2025

Last Update Posted Date

Mar 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EYP-1901 1343 µg	Experimental	EYP-1901 1343 µg, single dose	Drug: EYP-1901
EYP-1901 2686 µg	Experimental	EYP-1901 2686 µg, single dose	Drug: EYP-1901
Aflibercept	Active Comparator	Aflibercept 2 mg/0.05mL solution, single dose	Drug: Aflibercept 2Mg/0.05Ml Inj,Oph

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EYP-1901	Drug	Intravitreal Injection	EYP-1901 1343 µg EYP-1901 2686 µg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept	Timing of supplemental injection	Week 24

Secondary Outcomes

Measure	Description	Time Frame
Change in best corrected visual acuity (BCVA)	Changes in BCVA	Week 24

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ramiro Ribeiro, MD	EyePoint Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
EyePoint Investigative Site		Phoenix	Arizona	85020	United States
EyePoint Investigative Site

Intervention Browse Module

MeSH Terms

ID	Term
C000709220	vorolanib
C533178	aflibercept

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided