Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID07449923

A Phase 3, Multicenter, Randomized, Double-Masked Study Comparing EYP-1901 to Aflibercept in Participants With Diabetic Macular Edema

Led by EyePoint Pharmaceuticals, Inc. · Updated on 2026-06-03

240

Participants Needed

62

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of EYP-1901, a tyrosine kinase inhibitor, compared to Aflibercept in treating diabetic macular edema (DME). This phase 3, randomized, double-masked study aims to assess how well these treatments improve vision in participants with DME, a condition related to diabetic retinopathy that affects the central part of the retina. Participants will receive intravitreal injections of either EYP-1901 or Aflibercept. The study is designed with parallel groups and a quadruple masking approach, meaning neither participants nor researchers will know which treatment is given. The treatments will be administered according to the study schedule, with monitoring throughout the trial period. During the study, participants will undergo assessments including measuring best corrected visual acuity (BCVA) at 52 and 56 weeks to evaluate changes in vision. The study will also track the rate of injections needed by week 56. Safety and treatment effects will be monitored throughout the trial, which is expected to continue until October 2028.

CONDITIONS

Brief Title

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosed with macular edema associated with diabetic retinopathy in the study eye
  • Best corrected visual acuity (BCVA) score between 35 and 78 letters on the ETDRS chart in the study eye
  • For previously treated patients, at least one anti-VEGF injection in the past 12 months, with the last injection at least 12 weeks before screening
Not Eligible

You will not qualify if you...

  • BCVA score less than 30 letters on the ETDRS chart (20/250 Snellen equivalent) in the fellow eye

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 56 weeks

Participants receive intravitreal injections of either EYP-1901 or Aflibercept as part of the study treatment for diabetic macular edema.

Visits for injections and assessments scheduled during the treatment period

Trial Site Locations

Total: 62 locations

1

Associated Retina Consultans

Gilbert, Arizona, United States, 85297

Actively Recruiting

2

Associated Retina Consultants - Phoenix

Phoenix, Arizona, United States, 85020

Actively Recruiting

3

Phoenix Retina Clinical Trials, LLC - North Phoenix

Phoenix, Arizona, United States, 85050

Actively Recruiting

4

Retina Macula Institute of Arizona

Scottsdale, Arizona, United States, 85255

Actively Recruiting

5

Retina Vitreous Associates Medical Group

Beverly Hills, California, United States, 90211

Actively Recruiting

6

Retina Consultants of Orange County

Fullerton, California, United States, 92835

Actively Recruiting

7

South Coast Retina Center

Long Beach, California, United States, 90807

Actively Recruiting

8

Retinal Consultants Medical Group - Modesto

Modesto, California, United States, 95356

Actively Recruiting

9

Kaiser Permanente

Oakland, California, United States, 94611

Actively Recruiting

10

Retina Consultants of Southern California

Redlands, California, United States, 92374

Actively Recruiting

11

Bay Area Retina Associates

Walnut Creek, California, United States, 94598

Actively Recruiting

12

Retina Specialists of Colorado - Arvada

Arvada, Colorado, United States, 80002

Actively Recruiting

13

Connecticut Eye Consultants, P.C.

Danbury, Connecticut, United States, 06810

Actively Recruiting

14

Coastal Eye Surgeons, LLC

Greenwich, Connecticut, United States, 06830

Actively Recruiting

15

Retina Group of New England, PC

Waterford, Connecticut, United States, 06385

Actively Recruiting

16

Retina Group of Florida - Fort Lauderdale

Fort Lauderdale, Florida, United States, 33308

Actively Recruiting

17

Retina Specialty Institute

Pensacola, Florida, United States, 32503

Actively Recruiting

18

Fort Lauderdale Eye Institute

Plantation, Florida, United States, 33324

Actively Recruiting

19

MedEye Associates

South Miami, Florida, United States, 33143

Actively Recruiting

20

Retina Vitreous Associates of Florida - Saint Petersburg

St. Petersburg, Florida, United States, 33711

Actively Recruiting

21

Retina Vitreous Associates of Florida

Tampa, Florida, United States, 33617

Actively Recruiting

22

Retina Associates

Elmhurst, Illinois, United States, 60126

Actively Recruiting

23

University Retina and Macula Associates

Lemont, Illinois, United States, 60439

Actively Recruiting

24

Illinois Retina Associates, S.C.

Oak Park, Illinois, United States, 60304

Actively Recruiting

25

Associated Vitreoretinal & Uveitis Consultants - Carmel

Carmel, Indiana, United States, 46032

Actively Recruiting

26

The Eye Care Institute

Louisville, Kentucky, United States, 40206

Actively Recruiting

27

Mid Atlantic Retina Specialists - Hagerstown

Hagerstown, Maryland, United States, 21740

Actively Recruiting

28

The Retina Institute

St Louis, Missouri, United States, 63128

Actively Recruiting

29

Retina Center of New Jersey

Bloomfield, New Jersey, United States, 07003

Actively Recruiting

30

Vision Research Center at Eye Associates of New Mexico

Albuquerque, New Mexico, United States, 87109

Actively Recruiting

31

Retina Vitreous Surgeons of CNY, PC

Liverpool, New York, United States, 13088

Actively Recruiting

32

Graystone Eye - Hickory Office

Hickory, North Carolina, United States, 28602

Actively Recruiting

33

North Carolina Retina Associates

Wake Forest, North Carolina, United States, 27587

Actively Recruiting

34

Retina Vitreous Center, PLLC

Edmond, Oklahoma, United States, 73013

Actively Recruiting

35

Verum Research, LLC

Eugene, Oregon, United States, 97401

Actively Recruiting

36

Wills Eye Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

37

Carolinas Centers for Sight, P.C. - Florence Campus

Florence, South Carolina, United States, 29501

Actively Recruiting

38

Charles Retina Institute

Germantown, Tennessee, United States, 38138

Actively Recruiting

39

Austin Clinical Research LLC

Austin, Texas, United States, 78750

Actively Recruiting

40

Retina and Vitreous of Texas

Bellaire, Texas, United States, 77401

Actively Recruiting

41

Retina Consultants of Texas

Bellaire, Texas, United States, 77401

Actively Recruiting

42

San Antonio Eye Center

San Antonio, Texas, United States, 78215

Actively Recruiting

43

Retina Associates of South Texas

San Antonio, Texas, United States, 78240

Actively Recruiting

44

Retina Consultants of Texas

The Woodlands, Texas, United States, 77384

Actively Recruiting

45

Tyler Retina Consultants

Tyler, Texas, United States, 75703

Actively Recruiting

46

Strategic Clinical Research Group, LLC

Willow Park, Texas, United States, 76087

Actively Recruiting

47

The Retina Group of Washington

Fairfax, Virginia, United States, 22031

Actively Recruiting

48

Eye Clinic of Wisconsin

Wausau, Wisconsin, United States, 54403

Actively Recruiting

49

Retina Prime at Jardim Europa Medical Center

Aracaju, Brazil

Actively Recruiting

50

Centro Brasileiro de Pesquisa Clinica - Blumenau

Blumenau, Brazil

Actively Recruiting

51

IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia

São Paulo, Brazil

Actively Recruiting

52

Retina Clinic-Jardim America

São Paulo, Brazil

Actively Recruiting

53

Axon Clinical, s.r.o.

Prague, Czechia

Actively Recruiting

54

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Actively Recruiting

55

St Elisabeth Krankenhaus

Cologne, Germany

Actively Recruiting

56

Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, Hungary

Actively Recruiting

57

Budapest Retina Associates

Budapest, Hungary

Actively Recruiting

58

Semmelweis Egyetem

Budapest, Hungary

Actively Recruiting

59

Debreceni Egyetem KK Szemklinika

Debrecen, Hungary

Actively Recruiting

60

Ganglion Medical Center

Pécs, Hungary

Actively Recruiting

61

PTE KK Ophthalmology Clinic (Optimum Szemeszet)

Pécs, Hungary

Actively Recruiting

62

SzTE KK Szemeszeti Klinika

Szeged, Hungary

Actively Recruiting

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Research Team

R

Ramiro Ribeiro, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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