Clinical trial NCT05381948: Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)
Official title: A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wet Age-related Macular Degeneration
Keywords: wAMD
EYP-1901
EyePoint
Lead sponsor: EyePoint Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-19
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at two dose levels: 2060 ug and 3090 ug against Aflibercept.

Detailed description: This study is evaluating the two doses of 1901 against Aflibercept in a randomized study.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of wAMD in the study eye, with disease onset any time prior to the Screening Visit.
* Previously treated with at least two anti VEGF intravitreal injections (i.e., bevacizumab, ranibizumab, aflibercept or faricimab) for wAMD per standard of care in the study eye within 6 months prior to the Screening Visit.
* BCVA ETDRS letter score of 35 letters (20/200 Snellen equivalent) to 85 letters (20/20 Snellen equivalent) in the study eye at the Screening Visit and on Day 1.

Exclusion Criteria:

* Central subfield thickness (CST) \> 350 µm in the study eye at the Screening Visit or Day 1.
* Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma).
* Historical or active intraocular inflammation (grade trace or above) in the study eye, other than expected findings from routine cataract surgery.

Primary outcomes:
measure: Average change in best corrected visual acuity (BCVA)
timeFrame: Week 28 and Week 32
Secondary outcomes:
measure: Change in best corrected visual acuity (BCVA)
timeFrame: Baseline, Week 56
measure: Mean change in central retinal thickness on optical coherence tomography (OCT)
timeFrame: Baseline, Week 56
measure: Number of rescue injections
timeFrame: Week 56
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: EyePoint Investigative Site
state: Arizona
city: Springdale
country: United States
facility: EyePoint Investigative Site
state: Arkansas
city: Beverly Hills
country: United States
facility: EyePoint Investigative Site
state: California
city: Campbell
country: United States
facility: EyePoint Investigative Site
state: California
city: Encino
country: United States
facility: EyePoint Investigative Site
state: California
city: Fullerton
country: United States
facility: EyePoint Investigative Site
state: California
city: Glendale
country: United States
facility: EyePoint Investigative Site
state: California
city: Huntington Beach
country: United States
facility: EyePoint Investigative Site
state: California
city: Irvine
country: United States
facility: EyePoint Investigative Site
state: California
city: Pasadena
country: United States
facility: EyePoint Investigative Site
state: California
city: Poway
country: United States
facility: EyePoint Investigative Site
state: California
city: Redlands
country: United States
facility: EyePoint Investigative Site
state: California
city: Sacramento
country: United States
facility: EyePoint Investigative Site
state: California
city: Walnut Creek
country: United States
facility: EyePoint Investigative Site
state: California
city: Lakewood
country: United States
facility: EyePoint Investigative Site
state: Colorado
city: Clearwater
country: United States
facility: EyePoint Investigative Site
state: Florida
city: Coral Springs
country: United States
facility: EyePoint Investigative Site
state: Florida
city: Lakeland
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: Pensacola
country: United States
facility: EyePoint Investigative Site
state: Florida
city: Saint Petersburg
country: United States
facility: EyePoint Investigative Site
state: Florida
city: Sarasota
country: United States
facility: EyePoint Investigative Site
state: Florida
city: Tampa
country: United States
facility: EyePoint Investigative Site
state: Florida
city: Winter Haven
country: United States
facility: EyePoint Investigative Site
state: Florida
city: Marietta
country: United States
facility: EyePoint Investigative Site
state: Georgia
city: 'Aiea
country: United States
facility: EyePoint Investigative Site
state: Hawaii
city: Chicago
country: United States
facility: EyePoint Investigative Site
state: Illinois
city: Lemont
country: United States
facility: EyePoint Investigative Site
state: Illinois
city: Carmel
country: United States
facility: EyePoint Investigative Site
state: Indiana
city: West Des Moines
country: United States
facility: EyePoint Investigative Site
state: Iowa
city: Baltimore
country: United States
facility: EyePoint Investigative Site
state: Maryland
city: Hagerstown
country: United States
facility: EyePoint Investigative Site
state: Maryland
city: Owings Mills
country: United States
facility: EyePoint Investigative Site
state: Maryland
city: Boston
country: United States
facility: EyePoint Investigative Site
state: Massachusetts
city: Springfield
country: United States
facility: EyePoint Investigative Site
state: Massachusetts
city: Grand Rapids
country: United States
facility: EyePoint Investigative Site
state: Michigan
city: Saint Louis
country: United States
facility: EyePoint Investigative Site
state: Michigan
city: Saint Louis
country: United States
facility: EyePoint Investigative Site
state: Missouri
city: Reno
country: United States
facility: EyePoint Investigative Site
state: Nevada
city: Teaneck
country: United States
facility: EyePoint Investigative Site
state: New Jersey
city: Great Neck
country: United States
facility: EyePoint Investigative Site
state: New York
city: Hauppauge
country: United States
facility: EyePoint Investigative Site
state: New York
city: Liverpool
country: United States
facility: EyePoint Investigative Site
state: New York
city: Shirley
country: United States
facility: EyePoint Investigative Site
state: New York
city: Asheville
country: United States
facility: EyePoint Investigative Site
state: North Carolina
city: Wake Forest
country: United States
facility: EyePoint Investigative Site
state: North Carolina
city: Eugene
country: United States
facility: EyePoint Investigative Site
state: Oregon
city: Portland
country: United States
facility: EyePoint Investigative Site
state: Oregon
city: Springfield
country: United States
facility: EyePoint Investigative Site
state: Oregon
city: Charleston
country: United States
facility: EyePoint Investigative Site
state: South Carolina
city: West Columbia
country: United States
facility: EyePoint Investigative Site
state: South Carolina
city: Germantown
country: United States
facility: EyePoint Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: EyePoint Investigative Site
state: Tennessee
city: Abilene
country: United States
facility: EyePoint Investigative Site
state: Texas
city: Austin
country: United States
facility: EyePoint Investigative Sites
state: Texas
city: Dallas
country: United States
facility: EyePoint Investigative Site
state: Texas
city: Houston
country: United States
facility: EyePoint Investigative Sites
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: Salt Lake City
country: United States
facility: EyePoint Investigative Site
state: Utah
city: Fairfax
country: United States
facility: EyePoint Investigative Site
state: Virginia
city: Lynchburg
country: United States
facility: EyePoint Investigative Site
state: Virginia
city: Warrenton
country: United States
facility: EyePoint Investigative Site
state: Virginia
city: Silverdale
country: United States
facility: EyePoint Investigative Site
state: Washington
Study officials:
References: