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Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema

A Phase 2, Multicenter, Randomized, Double-Masked, Parallel-Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients With Diabetic Macular Edema

NCT06116916•Kyowa Kirin Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Voluntary written informed consent to participate in the study
•In Korea, participants must be 19 years or older to be enrolled
•BCVA ETDRS letter score of 78 letters to 35 letters as measured by the ETDRS visual acuity chart in the study eye at screening
•500 μm ≥ CST ≥ 325 μm in the study eye at screening
•HbA1c ≤ 11% at screening

Exclusion Criteria

•Any signs of proliferative diabetic retinopathy in the study eye
•History of rubeosis in the study eye
•Uncontrolled glaucoma in the study eye
•Aphakia or pseudophakia with AC-IOL in the study eye
•Active intraocular inflammation in the study eye
•Any current ocular condition for which visual acuity loss would not improve from resolution of macular edema in the study eye
•History of rhegmatogenous retinal detachment in the study eye
•Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
•History of the following therapies in the study eye
•* History of vitrectomy surgery, submacular surgery, or other surgical intervention for DME
+10 more criteria

Locations (87)

Barnet Dulaney Perkins Eye Center - Phoenix

Mesa, Arizona, United States

Retina Associates Southwest, P.C.

Tucson, Arizona, United States

Win Retina

Arcadia, California, United States

Retina Vitreous Associates Medical Group

Beverly Hills, California, United States

The Retina Partners

Encino, California, United States

Salehi Retina Institute, Inc

Huntington Beach, California, United States

California Eye Specialists Medical Group Inc

Pasadena, California, United States

Retina Consultants of Southern California

Redlands, California, United States

Retina Consultants of Southern CO

Colorado Springs, Colorado, United States

Blue Ocean Clinical Research West

Clearwater, Florida, United States

Key Dates

Start Date

January 9, 2024

Primary Completion Date

August 31, 2026

Completion Date

September 30, 2026

Last Updated

October 30, 2025

Enrollment

150

ESTIMATED participants

Conditions

Diabetic Macular Edema (DME)

Interventions

KHK4951

DRUG

Aflibercept Injection

DRUG

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

NCT07449936

Diabetic Macular EdemaDME+1 more

View study

RECRUITINGPHASE3

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

NCT07449923

Diabetic Macular EdemaDME+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema

Inclusion Criteria

Exclusion Criteria

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

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

A Study of Avoralstat In Participants With Diabetic Macular Edema

A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting

Phase 4 IOP Signals Associated With ILUVIEN®