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Phase 1 open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of a single dose injections of EYP-1901 at three dose levels: 440 µg, 2060 µg and 3090 µg in subjects with Wet Age Related Macular Degeneration (wAMD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 440 ug, single dose | Experimental | EYP-1901 440 ug, single dose |
|
| 2060 ug, single dose | Experimental | EYP-1901 2060 ug, single dose |
|
| 3090 ug, single dose | Experimental | EYP-1901 3090 ug, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EYP-1901 | Drug | Intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs) | Number of ocular (study eye) and systemic TEAEs during the treatment period - Intent-to-Treat (ITT) Population | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in best corrected visual acuity (BCVA) by EDTRS | Mean change from Baseline in BCVA in the Study Eye | Baseline, Week 48 |
| Mean change in central subfield thickness (CST) | Mean change from Baseline in CST measured in microns by Spectral-domain - optical coherence tomography (OCT) assessments by a study-certified OCT technician in the study eye |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EyePoint Investigational Site | Phoenix | Arizona | 85053 | United States | ||
| EyePoint Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38881599 | Derived | Patel S, Storey PP, Barakat MR, Hershberger V, Bridges WZ Jr, Eichenbaum DA, Lally DR, Boyer DS, Bakri SJ, Roy M, Paggiarino DA. Phase I DAVIO Trial: EYP-1901 Bioerodible, Sustained-Delivery Vorolanib Insert in Patients With Wet Age-Related Macular Degeneration. Ophthalmol Sci. 2024 Apr 9;4(5):100527. doi: 10.1016/j.xops.2024.100527. eCollection 2024 Sep-Oct. |
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| Baseline, Week 48 |
| Beverly Hills |
| California |
| 90211 |
| United States |
| EyePoint Investigative Site | Mountain View | California | 94040 | United States |
| EyePoint Investigational Site | Oxnard | California | 93036 | United States |
| EyePoint Investigational Site | Melbourne | Florida | 32901 | United States |
| EyePoint Investigational Site | St. Petersburg | Florida | 33711 | United States |
| EyePoint Investigational Site | Springfield | Massachusetts | 01107 | United States |
| EyePoint Investigative Site | Asheville | North Carolina | 28803 | United States |
| EyePoint Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| EyePoint Investigational Site | Abilene | Texas | 79606 | United States |
| EyePoint Investigational Site | Austin | Texas | 78705 | United States |