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

Launched by KYOWA KIRIN CO., LTD. · Oct 31, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of a new treatment called KHK4951, which comes in the form of eye drops, for patients with a condition known as Diabetic Macular Edema (DME). DME is a complication of diabetes that can lead to vision problems. The study is currently recruiting participants who are 19 years or older and have specific vision and health criteria, such as having a certain level of vision impairment and a controlled blood sugar level.

If you choose to participate, you'll be asked to give your written consent and undergo some tests to ensure you're eligible. During the trial, you'll use the eye drops and be monitored for any changes in your vision and overall eye health. It's important to know that certain conditions or previous treatments could make you ineligible for the study, so discussing your medical history with the research team is essential. This trial aims to find out if KHK4951 can help improve vision in people with DME and to ensure it is safe to use.

Gender

ALL

Eligibility criteria

• 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