Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (NCT05381948) | Clinical Trial Compass
CompletedPhase 2
Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)
United States161 participantsStarted 2022-06-30
Plain-language summary
This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at 2 dose levels: 2060 microgram (mcg) and 3090 mcg against aflibercept.
Who can participate
Age range50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented diagnosis of wAMD in the study eye, with disease onset any time prior to the Screening Visit.
* Documented anatomical response (that is, reduction in fluid on \[spectral-domain - optical coherence tomography (SD-OCT)\] to previous intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections in the study eye prior to the Screening Visit.
* Previously treated with at least 2 anti-VEGF intravitreal injections (that is, bevacizumab, ranibizumab, aflibercept or faricimab) for wAMD per standard of care in the study eye within 6 months prior to the Screening Visit.
* Received previous anti-VEGF therapy 2 to 5 weeks (14 to 35 days) in the study eye prior to Screening Visit, but no more than 42 days prior to randomization to study treatment on Day 1.
* Best corrected visual acuity (BCVA) early Treatment Diabetic Retinopathy Study (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.
* Able to understand, and willingness to sign, the informed consent and to provide access to personal health information via Health Insurance Portability and Accountability Act (HIPAA) authorization.
* Willingness and ability to comply with all scheduled visits, restrictions, and assessments.
* For women of childbearing potential, or men with female partners of childbearing potential, agreement to the use of an appropriate form of contraception at the Screā¦
What they're measuring
1
Average Change in Best Corrected Visual Acuity (BCVA) From Baseline Averaged Over Weeks 28 and 32