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

Running, not enrolling · Phase 2

Conditions studied: Diabetic Macular Edema (DME)

In brief

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

Key facts

Study ID

NCT06116916

Run by

Kyowa Kirin Co., Ltd.

People needed

150

Starts

2024-01-09

Expected to finish

2026-09-30

Last updated by the study team

2025-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ft. Lauderdale Eye Institute — Plantation, Florida, United States
• Retina Vitreous Associates of Florida - Saint Petersburg — St. Petersburg, Florida, United States
• Southern Vitreoretinal Associates — Tallahassee, Florida, United States
• Center for Retina and Macular Disease - Ophthalmology — Winter Haven, Florida, United States
• Mid Atlantic Retina Specialists - Hagerstown — Hagerstown, Maryland, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Envision Ocular, LLC — Bloomfield, New Jersey, United States
• Vision Research Center Eye Associates of New Mexico — Albuquerque, New Mexico, United States
• Retina Vitreous Surgeons of Central NY, PC — Liverpool, New York, United States
• Ophthalmic Consultants of Long Island — Oceanside, New York, United States
• Retina Vitreous Center in Edmond Oklahoma — Edmond, Oklahoma, United States
• EyeHealth Northwest — Portland, Oregon, United States
• Wills Eye Health System — Bethlehem, Pennsylvania, United States
• Eye Care Specialists — Kingston, Pennsylvania, United States
• Retina Consultants of Charleston - (RCA Network Site) — Charleston, South Carolina, United States
• Charleston Neuroscience Institute (RCA Network Site) — Ladson, South Carolina, United States
• Black Hills Regional Eye Institute - Ophthalmology — Rapid City, South Dakota, United States
• Charles Retina Institute — Germantown, Tennessee, United States
• Retina Research Institute of Texas — Abilene, Texas, United States
• Austin Retina Associates - Ophthalmology/Retina (RCA Network site) — Austin, Texas, United States
• Austin Clinical Research, LLC — Austin, Texas, United States
• Retina Consultants of Texas — Bellaire, Texas, United States
• Texas Retina Associates — Fort Worth, Texas, United States
• Retinal Consultants of Texas- San Antonio (RCA Network site) — San Antonio, Texas, United States
• Eye Associates of Pinellas — Pinellas Park, Florida, United States

Full record on ClinicalTrials.gov

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