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Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)

Sponsor
EyePoint Pharmaceuticals, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05383209
Collaborator
(none)
105
Enrollment
3
Arms
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Prospective, Double-masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Sham for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: EYP-1901 2060 ug

EYP-1901 2060 ug; single injection

Drug: EYP-1901
Intravitreal Injection
Experimental: EYP-1901 3090 ug

EYP-1901 3090 ug; single injection

Drug: EYP-1901
Intravitreal Injection
Sham Comparator: Sham IVT

Sham IVT; single injection

Other: Sham IVT
Sham IVT

Outcome Measures

Primary Outcome Measures

  1. Percentage of subjects improving ≥2 steps in the Diabetic Retinopathy Severity Scale (DRSS) score each EYP-1901 dose level versus the sham IVT injection group. [Baseline, Week 24]

Secondary Outcome Measures

  1. Percentage of subjects improving ≥2 steps in the DRSS score in each dose level vs. sham [Baseline, Week 48, Week 96]

  2. Percentage of subjects who developed a vision-threatening complication due to diabetic retinopathy [Week 24, Week 48, Week 96]

  3. Rates of ocular (study eye and fellow eye) and non-ocular Treatment-Emergent Adverse Events [Week 24, Week 48, Week 96]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Participants must have a hemoglobin A1c ≤12%

  • Study eye with moderately severe to severe NPDR (based on the DRSS levels 47 or 53)

  • Best corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better).

Exclusion Criteria:

  • Presence of any active Center involved-diabetic macular edema in the study eye as determined by the Investigator on clinical examination, or within the central subfield thickness (CST) of the study eye, with a CST threshold greater than 320 microns.

  • Any evidence or documented history of prior focal or grid laser photocoagulation or any pan-retinal photocoagulation in the study eye in the last 12 months.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • EyePoint Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EyePoint Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT05383209
Other Study ID Numbers:
  • EYP-1901-204
First Posted:
May 20, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by EyePoint Pharmaceuticals, Inc.
NPDR
EYP-1901
EyePoint
Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy

Study Results

No Results Posted as of Aug 5, 2022