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Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (DAVIO2)

Primary Purpose

Wet Age-related Macular Degeneration

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Eyp-1901
Aflibercept 2Mg/0.05Ml Inj,Oph
Sponsored by
EyePoint Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Age-related Macular Degeneration focused on measuring wAMD, EYP-1901, EyePoint

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented diagnosis of wAMD in the study eye, with disease onset within 9 months prior to the Screening Visit.
  • Previously treated with at least two anti VEGF intravitreal injections (i.e., bevacizumab, ranibizumab, or aflibercept) 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 80 letters (20/25 Snellen equivalent) in the study eye at the Screening Visit and on Day 1.

Exclusion Criteria:

  • Central subfield thickness (CST) > 400 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.

Sites / Locations

  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Sites
  • EyePoint Investigative Site
  • EyePoint Investigative Sites
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site
  • EyePoint Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

EYP-1901 2060 ug

EYP-1901 3090 ug

Aflibercept

Arm Description

EYP-1901 2060 ug, single dose

EYP-1901 3090 ug, single dose

Aflibercept 2 mg [0.05mL] every 8 weeks

Outcomes

Primary Outcome Measures

Average change in best corrected visual acuity (BCVA)

Secondary Outcome Measures

Change in best corrected visual acuity (BCVA)
Mean change in central retinal thickness on optical coherence tomography (OCT)
Number of rescue injections

Full Information

First Posted
May 9, 2022
Last Updated
July 18, 2023
Sponsor
EyePoint Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05381948
Brief Title
Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)
Acronym
DAVIO2
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 28, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EyePoint Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Age-related Macular Degeneration
Keywords
wAMD, EYP-1901, EyePoint

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EYP-1901 2060 ug
Arm Type
Experimental
Arm Description
EYP-1901 2060 ug, single dose
Arm Title
EYP-1901 3090 ug
Arm Type
Experimental
Arm Description
EYP-1901 3090 ug, single dose
Arm Title
Aflibercept
Arm Type
Active Comparator
Arm Description
Aflibercept 2 mg [0.05mL] every 8 weeks
Intervention Type
Drug
Intervention Name(s)
Eyp-1901
Intervention Description
Intravitreal Injection
Intervention Type
Drug
Intervention Name(s)
Aflibercept 2Mg/0.05Ml Inj,Oph
Other Intervention Name(s)
Eylea
Intervention Description
Intravitreal Injection
Primary Outcome Measure Information:
Title
Average change in best corrected visual acuity (BCVA)
Time Frame
Week 28 and Week 32
Secondary Outcome Measure Information:
Title
Change in best corrected visual acuity (BCVA)
Time Frame
Baseline, Week 56
Title
Mean change in central retinal thickness on optical coherence tomography (OCT)
Time Frame
Baseline, Week 56
Title
Number of rescue injections
Time Frame
Week 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
EyePoint Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
EyePoint Investigative Site
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
EyePoint Investigative Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
EyePoint Investigative Site
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
EyePoint Investigative Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
EyePoint Investigative Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
EyePoint Investigative Site
City
Glendale
State/Province
California
ZIP/Postal Code
91203
Country
United States
Facility Name
EyePoint Investigative Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
EyePoint Investigative Site
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
EyePoint Investigative Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
EyePoint Investigative Site
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
EyePoint Investigative Site
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
EyePoint Investigative Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
EyePoint Investigative Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
EyePoint Investigative Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
EyePoint Investigative Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
EyePoint Investigative Site
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
EyePoint Investigative Site
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
EyePoint Investigative Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
EyePoint Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
EyePoint Investigative Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
EyePoint Investigative Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
EyePoint Investigative Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
EyePoint Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
EyePoint Investigative Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
EyePoint Investigative Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
EyePoint Investigative Site
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
EyePoint Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
EyePoint Investigative Site
City
Lemont
State/Province
Illinois
ZIP/Postal Code
60439
Country
United States
Facility Name
EyePoint Investigative Site
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
EyePoint Investigative Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
EyePoint Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
EyePoint Investigative Site
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
EyePoint Investigative Site
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
EyePoint Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
EyePoint Investigative Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
EyePoint Investigative Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49446
Country
United States
Facility Name
EyePoint Investigative Site
City
Saint Louis
State/Province
Michigan
ZIP/Postal Code
55416
Country
United States
Facility Name
EyePoint Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
EyePoint Investigative Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
EyePoint Investigative Site
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
EyePoint Investigative Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
EyePoint Investigative Site
City
Hauppauge
State/Province
New York
ZIP/Postal Code
11788
Country
United States
Facility Name
EyePoint Investigative Site
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
EyePoint Investigative Site
City
Shirley
State/Province
New York
ZIP/Postal Code
11967
Country
United States
Facility Name
EyePoint Investigative Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
EyePoint Investigative Site
City
Wake Forest
State/Province
North Carolina
ZIP/Postal Code
27587
Country
United States
Facility Name
EyePoint Investigative Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
EyePoint Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
EyePoint Investigative Site
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97488
Country
United States
Facility Name
EyePoint Investigative Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
EyePoint Investigative Site
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
EyePoint Investigative Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
EyePoint Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
EyePoint Investigative Site
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
EyePoint Investigative Sites
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
EyePoint Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
EyePoint Investigative Sites
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
EyePoint Investigative Site
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
EyePoint Investigative Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
EyePoint Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
EyePoint Investigative Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
EyePoint Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
EyePoint Investigative Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
EyePoint Investigative Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
EyePoint Investigative Site
City
Warrenton
State/Province
Virginia
ZIP/Postal Code
20186
Country
United States
Facility Name
EyePoint Investigative Site
City
Silverdale
State/Province
Washington
ZIP/Postal Code
98383
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)

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