Diabetic Macular Edema (DME)
Conditions
Brief summary
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
Interventions
DRUGKHK4951
KHK4951 eye drop for 36 weeks until end of the trial
Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline | For 36 weeks until the end of the trial |
Secondary
| Measure | Time frame |
|---|---|
| The number of aflibercept IVT | For 36 weeks until the end of the trial |
| Change from baseline in SHRM as measured by SD-OCT | 36 Weeks |
| Change from baseline in retinal morphology as measured by SD-OCT | 36 Weeks |
| Change from baseline in leakage as measured by FA | 36 Weeks |
Other
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | For 36 weeks until the end of the trial |
| Serum KHK4951 concentration | 36 Weeks |
Countries
Australia, Japan, South Korea, United States
Outcome results
None listed