Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)
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|ClinicalTrials.gov Identifier: NCT05381948|
Recruitment Status : Recruiting
First Posted : May 19, 2022
Last Update Posted : February 14, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Wet Age-related Macular Degeneration||Drug: Eyp-1901 Drug: Aflibercept 2Mg/0.05Ml Inj,Oph||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Study Start Date :||July 28, 2022|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: EYP-1901 2060 ug
EYP-1901 2060 ug, single dose
Experimental: EYP-1901 3090 ug
EYP-1901 3090 ug, single dose
Active Comparator: Aflibercept
Aflibercept 2 mg [0.05mL] every 8 weeks
Drug: Aflibercept 2Mg/0.05Ml Inj,Oph
Other Name: Eylea
- Average change in best corrected visual acuity (BCVA) [ Time Frame: Week 28 and Week 32 ]
- Change in best corrected visual acuity (BCVA) [ Time Frame: Baseline, Week 56 ]
- Mean change in central retinal thickness on optical coherence tomography (OCT) [ Time Frame: Baseline, Week 56 ]
- Number of rescue injections [ Time Frame: Week 56 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05381948
|Contact: Dario Paggiarino, MDemail@example.com|
|Responsible Party:||EyePoint Pharmaceuticals, Inc.|
|Other Study ID Numbers:||
|First Posted:||May 19, 2022 Key Record Dates|
|Last Update Posted:||February 14, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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