Trials Today

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

Purpose

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

Condition

Diabetic Macular Edema (DME)

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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 - 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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Arm A	KHK4951 High dose	Drug: KHK4951 KHK4951 eye drop for 36 weeks until end of the trial Drug: Aflibercept Injection Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
Experimental Arm B	KHK4951 Middle dose	Drug: KHK4951 KHK4951 eye drop for 36 weeks until end of the trial Drug: Aflibercept Injection Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
Experimental Arm C	KHK4951 Low dose	Drug: KHK4951 KHK4951 eye drop for 36 weeks until end of the trial Drug: Aflibercept Injection Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol

Recruiting Locations

More Details

NCT ID: NCT06116916
Status: Active, not recruiting
Sponsor: Kyowa Kirin Co., Ltd.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.