Home › Trials › NCT07449923

CAPRI: EYP-1901 versus aflibercept for diabetic macular edema

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)

Phase 3 Interventional EyePoint Pharmaceuticals, Inc. · NCT07449923

This Phase 3 trial will test whether a long-acting eye medicine called EYP-1901 works as well as regular aflibercept injections for people with diabetic macular edema.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years and up
SexAll
SponsorEyePoint Pharmaceuticals, Inc. Industry-sponsored
Locations48 sites (Gilbert, Arizona and 47 other locations)
Trial IDNCT07449923 on ClinicalTrials.gov

What this trial studies

CAPRI is a randomized, double-masked Phase 3 comparison of EYP-1901 against aflibercept (2.0 mg) in patients with diabetic macular edema. Participants who are treatment-naïve or previously treated with anti-VEGF agents are eligible, with enrollment based on specified visual acuity ranges. The study randomizes participants to receive either EYP-1901 or aflibercept and follows outcomes including vision and retinal anatomy over the trial period. The sponsor is EyePoint Pharmaceuticals and study sites are retina specialty clinics in Arizona.

Who should consider this trial

Good fit: Adults with diabetic macular edema in the study eye with BCVA between 35 and 78 ETDRS letters (≈20/200 to 20/32), who may be treatment-naïve or have had at least one anti-VEGF injection in the past 12 months (with the last anti-VEGF ≥12 weeks before screening), are the intended participants.

Not a fit: Patients with very poor vision in the fellow eye, other significant ocular disease, or who do not meet the trial’s BCVA or prior-treatment timing requirements are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, EYP-1901 could maintain vision while reducing the frequency of injections compared with standard aflibercept therapy.

How similar studies have performed: Aflibercept is an established effective treatment for DME, and earlier-phase studies of EYP-1901 have reported promising durability and visual/anatomic signals, though confirmatory Phase 3 data are needed.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* BCVA using ETDRS charts \<30 letters (20/250 Snellen equivalent) in the fellow eye.

Where this trial is running

Gilbert, Arizona and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetic Macular EdemaDMEEyePointTyrosine Kinase InhibitorEYP-1901
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.