ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-01-09

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06116916

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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 * Periocular or intraocular (sub-Tenon or IVT) corticosteroids within 12 weeks prior to Day 1 corticosteroids * Previous intraocular device implantation except PC-IOL * Laser (any type) to the macular area within 12 weeks prior to Day 1 * Peripheral retinal photocoagulation therapy within 12 weeks prior to Day 1 * Previous treatment with IVT anti-VEGF drugs other than ranibizumab, bevacizumab, aflibercept 2 mg, and their biosimilars * Treatment with ranibizumab, bevacizumab, aflibercept 2 mg, or their biosimilars within 12 weeks prior to Day 1. Previously treated patients who received these medications more than 12 weeks prior to Day 1 can be enrolled, but the patients should be diagnosed with DME within 3 years prior to Day 1 * Previous use of Ozurdex® or Iluvien® implant * Any current or history of endophthalmitis in either eye * History of idiopathic or autoimmune-associated uveitis in either eye * Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

Inclusion Criteria

Exclusion 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

* 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
* Periocular or intraocular (sub-Tenon or IVT) corticosteroids within 12 weeks prior to Day 1 corticosteroids
* Previous intraocular device implantation except PC-IOL
* Laser (any type) to the macular area within 12 weeks prior to Day 1
* Peripheral retinal photocoagulation therapy within 12 weeks prior to Day 1
* Previous treatment with IVT anti-VEGF drugs other than ranibizumab, bevacizumab, aflibercept 2 mg, and their biosimilars
* Treatment with ranibizumab, bevacizumab, aflibercept 2 mg, or their biosimilars within 12 weeks prior to Day 1. Previously treated patients who received these medications more than 12 weeks prior to Day 1 can be enrolled, but the patients should be diagnosed with DME within 3 years prior to Day 1
* Previous use of Ozurdex® or Iluvien® implant
* Any current or history of endophthalmitis in either eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

Contacts and Locations

Principal Investigator

Sotaro Takigawa

STUDY_DIRECTOR

Kyowa Kirin Co., Ltd.

Study Locations (Sites)

Barnet Dulaney Perkins Eye Center - Phoenix

Mesa, Arizona, 85206

United States

Retina Associates Southwest, P.C.

Tucson, Arizona, 85710

United States

Win Retina

Arcadia, California, 91006

United States

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211

United States

The Retina Partners

Encino, California, 91436

United States

Salehi Retina Institute, Inc

Huntington Beach, California, 92647

United States

California Eye Specialists Medical Group Inc

Pasadena, California, 91107

United States

Retina Consultants of Southern California

Redlands, California, 92374

United States

Retina Consultants of Southern CO

Colorado Springs, Colorado, 80909

United States

Blue Ocean Clinical Research West

Clearwater, Florida, 33761

United States

Florida Eye Associates

Melbourne, Florida, 32901

United States

Eye Associates of Pinellas

Pinellas Park, Florida, 33782

United States

Ft. Lauderdale Eye Institute

Plantation, Florida, 33324

United States

Retina Vitreous Associates of Florida - Saint Petersburg

St. Petersburg, Florida, 33711

United States

Southern Vitreoretinal Associates

Tallahassee, Florida, 32308

United States

Center for Retina and Macular Disease - Ophthalmology

Winter Haven, Florida, 33880

United States

Mid Atlantic Retina Specialists - Hagerstown

Hagerstown, Maryland, 21740

United States

Sierra Eye Associates

Reno, Nevada, 89502

United States

Envision Ocular, LLC

Bloomfield, New Jersey, 07003

United States

Vision Research Center Eye Associates of New Mexico

Albuquerque, New Mexico, 87109

United States

Retina Vitreous Surgeons of Central NY, PC

Liverpool, New York, 13088

United States

Ophthalmic Consultants of Long Island

Oceanside, New York, 11572

United States

Retina Vitreous Center in Edmond Oklahoma

Edmond, Oklahoma, 73013

United States

EyeHealth Northwest

Portland, Oregon, 97225

United States

Wills Eye Health System

Bethlehem, Pennsylvania, 18017

United States

Eye Care Specialists

Kingston, Pennsylvania, 18704

United States

Retina Consultants of Charleston - (RCA Network Site)

Charleston, South Carolina, 29414

United States

Charleston Neuroscience Institute (RCA Network Site)

Ladson, South Carolina, 29456

United States

Black Hills Regional Eye Institute - Ophthalmology

Rapid City, South Dakota, 57701

United States

Charles Retina Institute

Germantown, Tennessee, 38138

United States

Retina Research Institute of Texas

Abilene, Texas, 79606

United States

Austin Retina Associates - Ophthalmology/Retina (RCA Network site)

Austin, Texas, 78705

United States

Austin Clinical Research, LLC

Austin, Texas, 78750

United States

Retina Consultants of Texas

Bellaire, Texas, 77401

United States

Texas Retina Associates

Fort Worth, Texas, 76104

United States

Retinal Consultants of Texas- San Antonio (RCA Network site)

San Antonio, Texas, 78240

United States

Retina Consultants of Texas (RCA Network Site)

The Woodlands, Texas, 77384

United States

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087

United States

University of Vermont Fletcher Allen Health Care

Burlington, Vermont, 05401

United States

Retina Group of Washington

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Kyowa Kirin Co., Ltd.

Sotaro Takigawa, STUDY_DIRECTOR, Kyowa Kirin Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-09

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2024-01-09

Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

Diabetic Macular Edema (DME)