Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: EYP-1901 2060 ug EYP-1901 2060 ug, single dose |
Drug: Eyp-1901
Intravitreal Injection
|
Experimental: EYP-1901 3090 ug EYP-1901 3090 ug, single dose |
Drug: Eyp-1901
Intravitreal Injection
|
Active Comparator: Aflibercept Aflibercept 2 mg [0.05mL] every 8 weeks |
Drug: Aflibercept 2Mg/0.05Ml Inj,Oph
Intravitreal Injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Average change in best corrected visual acuity (BCVA) [Week 28 and Week 32]
Secondary Outcome Measures
- Change in best corrected visual acuity (BCVA) [Baseline, Week 56]
- Mean change in central retinal thickness on optical coherence tomography (OCT) [Baseline, Week 56]
- Number of rescue injections [Week 56]
Eligibility Criteria
Criteria
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:
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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).
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Historical or active intraocular inflammation (grade trace or above) in the study eye, other than expected findings from routine cataract surgery.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | EyePoint Investigative Site | Melbourne | Florida | United States | 32901 |
2 | EyePoint Investigative Sites | Austin | Texas | United States | 78705 |
3 | EyePoint Investigative site | Dallas | Texas | United States | 75231 |
4 | EyePoint Investigative Sites | Houston | Texas | United States | 77025 |
5 | EyePoint Investigative Site | San Antonio | Texas | United States | 78247 |
Sponsors and Collaborators
- EyePoint Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EYP-1901-201