Enrollment on hold
A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)
NCT No.: NCT07449923
Study Type: INTERVENTIONAL
Phase:
Phase III
Region: California - Northern
Acronym: CAPRI
Official Title
A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)
Purpose
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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* Previously treated or treatment naïve patients with a documented diagnosis of macular edema associated with diabetic retinopathy (DR) in the study eye, with onset of disease that began at any time prior to the Screening Visit.
* Best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 35 letters (20/200 Snellen equivalent) to 78 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).
* For previously treated participants: at least 1 injection of anti-VEGF in the past 12 months, the most recent anti-VEGF treatment for DME must not have been administered less than 12 weeks prior to the Screening Visit.
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Exclusion Criteria
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* BCVA using ETDRS charts \<30 letters (20/250 Snellen equivalent) in the fellow eye.
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Keywords and/or Specific Medical Conditions
Sponsors
- EyePoint Pharmaceuticals, Inc.
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