Clinical trial NCT05383209: Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonproliferative Diabetic Retinopathy
Keywords: NPDR
EYP-1901
EyePoint
Lead sponsor: EyePoint Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-20
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This study will evaluate the the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to sham using a randomized double masked trial design.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline, Week 36
Secondary outcomes:
measure: Percentage of subjects improving ≥2 steps in the DRSS score in each dose level vs. sham
timeFrame: Baseline, Week 24, Week 48
measure: Percentage of subjects who developed a vision-threatening complication due to diabetic retinopathy
timeFrame: Week 24, Week 36, Week 48
measure: Rates of ocular (study eye and fellow eye) and non-ocular Treatment-Emergent Adverse Events
timeFrame: Week 24, Week 36, Week 48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: EyePoint Investigative Site
state: Arizona
city: Huntington Beach
country: United States
facility: EyePoint Investigative Site
state: California
city: Oxnard
country: United States
facility: EyePoint Investigative Site
state: California
city: Palm Desert
country: United States
facility: EyePoint Investigative Site
state: California
city: Pasadena
country: United States
facility: EyePoint Investigative Site
state: California
city: Sacramento
country: United States
facility: EyePoint Investigative Site
state: California
city: Clearwater
country: United States
facility: EyePoint Investigative Site
state: Florida
city: Melbourne
country: United States
facility: EyePoint Investigative Site
state: Florida
city: Miami
country: United States
facility: EyePoint Investigative Site
state: Florida
city: Winter Haven
country: United States
facility: EyePoint Investigative Site
state: Florida
city: Lemont
country: United States
facility: EyePoint Investigative Site
state: Illinois
city: Indianapolis
country: United States
facility: EyePoint Investigative Site
state: Indiana
city: Lenexa
country: United States
facility: EyePoint Investigative Site
state: Kansas
city: Springfield
country: United States
facility: EyePoint Investigative Site
state: Massachusetts
city: Reno
country: United States
facility: EyePoint Investigative Site
state: Nevada
city: Toms River
country: United States
facility: EyePoint Investigative Site
state: New Jersey
city: Florence
country: United States
facility: EyePoint Investigative Site
state: South Carolina
city: Ladson
country: United States
facility: EyePoint Investigative Site
state: South Carolina
city: Germantown
country: United States
facility: EyePoint Investigative Site
state: Tennessee
city: Austin
country: United States
facility: EyePoint Investigative Site
state: Texas
city: Houston
country: United States
facility: EyePoint Investigative Site
state: Texas
city: McAllen
country: United States
facility: EyePoint Investigative Site
state: Texas
city: Plano
country: United States
facility: EyePoint Investigative Site
state: Texas
city: San Antonio
country: United States
facility: EyePoint Investigative Site
state: Texas
city: The Woodlands
country: United States
facility: EyePoint Investigative Site
state: Texas
city: Bellevue
country: United States
facility: EyePoint Investigative Site
state: Washington
Study officials:
affiliation: EyePoint Pharmaceuticals
name: Ramiro Ribeiro, MD
role: STUDY_DIRECTOR
References: