Wet Age-related Macular Degeneration Clinical Trial
— DAVIO2Official 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
| Verified date | May 2023 |
| Source | EyePoint Pharmaceuticals, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 160 |
| Est. completion date | April 2024 |
| Est. primary completion date | November 7, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | EyePoint Investigative Site | 'Aiea | Hawaii |
| United States | EyePoint Investigative Site | Abilene | Texas |
| United States | EyePoint Investigative Site | Asheville | North Carolina |
| United States | EyePoint Investigative Sites | Austin | Texas |
| United States | EyePoint Investigative Site | Baltimore | Maryland |
| United States | EyePoint Investigative Site | Beverly Hills | California |
| United States | EyePoint Investigative Site | Boston | Massachusetts |
| United States | EyePoint Investigative Site | Campbell | California |
| United States | EyePoint Investigative Site | Carmel | Indiana |
| United States | EyePoint Investigative Site | Charleston | South Carolina |
| United States | EyePoint Investigative Site | Chicago | Illinois |
| United States | EyePoint Investigative Site | Clearwater | Florida |
| United States | EyePoint Investigative Site | Coral Springs | Florida |
| United States | EyePoint Investigative Site | Dallas | Texas |
| United States | EyePoint Investigative Site | Encino | California |
| United States | EyePoint Investigative Site | Eugene | Oregon |
| United States | EyePoint Investigative Site | Fairfax | Virginia |
| United States | EyePoint Investigative Site | Fullerton | California |
| United States | EyePoint Investigative Site | Germantown | Tennessee |
| United States | EyePoint Investigative Site | Glendale | California |
| United States | EyePoint Investigative Site | Grand Rapids | Michigan |
| United States | EyePoint Investigative Site | Great Neck | New York |
| United States | EyePoint Investigative Site | Hagerstown | Maryland |
| United States | EyePoint Investigative Site | Hauppauge | New York |
| United States | EyePoint Investigative Sites | Houston | Texas |
| United States | EyePoint Investigative Site | Huntington Beach | California |
| United States | EyePoint Investigative Site | Irvine | California |
| United States | EyePoint Investigative Site | Lakeland | Florida |
| United States | EyePoint Investigative Site | Lakewood | Colorado |
| United States | EyePoint Investigative Site | Lemont | Illinois |
| United States | EyePoint Investigative Site | Liverpool | New York |
| United States | EyePoint Investigative Site | Lynchburg | Virginia |
| United States | EyePoint Investigative Site | Marietta | Georgia |
| United States | EyePoint Investigative Site | McAllen | Texas |
| United States | EyePoint Investigative Site | Melbourne | Florida |
| United States | EyePoint Investigative Site | Miami | Florida |
| United States | EyePoint Investigative Site | Nashville | Tennessee |
| United States | EyePoint Investigative Site | Owings Mills | Maryland |
| United States | EyePoint Investigative Site | Pasadena | California |
| United States | EyePoint Investigative Site | Pensacola | Florida |
| United States | EyePoint Investigative Site | Phoenix | Arizona |
| United States | EyePoint Investigative Site | Plano | Texas |
| United States | EyePoint Investigative Site | Portland | Oregon |
| United States | EyePoint Investigative Site | Poway | California |
| United States | EyePoint Investigative Site | Redlands | California |
| United States | EyePoint Investigative Site | Reno | Nevada |
| United States | EyePoint Investigative Site | Sacramento | California |
| United States | EyePoint Investigative Site | Saint Louis | Michigan |
| United States | EyePoint Investigative Site | Saint Louis | Missouri |
| United States | EyePoint Investigative Site | Saint Petersburg | Florida |
| United States | EyePoint Investigative Site | Salt Lake City | Utah |
| United States | EyePoint Investigative Site | San Antonio | Texas |
| United States | EyePoint Investigative Site | Sarasota | Florida |
| United States | EyePoint Investigative Site | Shirley | New York |
| United States | EyePoint Investigative Site | Silverdale | Washington |
| United States | EyePoint Investigative Site | Springdale | Arkansas |
| United States | EyePoint Investigative Site | Springfield | Massachusetts |
| United States | EyePoint Investigative Site | Springfield | Oregon |
| United States | EyePoint Investigative Site | Tampa | Florida |
| United States | EyePoint Investigative Site | Teaneck | New Jersey |
| United States | EyePoint Investigative Site | The Woodlands | Texas |
| United States | EyePoint Investigative Site | Wake Forest | North Carolina |
| United States | EyePoint Investigative Site | Walnut Creek | California |
| United States | EyePoint Investigative Site | Warrenton | Virginia |
| United States | EyePoint Investigative Site | West Columbia | South Carolina |
| United States | EyePoint Investigative Site | West Des Moines | Iowa |
| United States | EyePoint Investigative Site | Winter Haven | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| EyePoint Pharmaceuticals, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Average change in best corrected visual acuity (BCVA) | Week 28 and Week 32 | ||
| Secondary | Change in best corrected visual acuity (BCVA) | Baseline, Week 56 | ||
| Secondary | Mean change in central retinal thickness on optical coherence tomography (OCT) | Baseline, Week 56 | ||
| Secondary | Number of rescue injections | Week 56 |
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