Status:
ACTIVE_NOT_RECRUITING
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Diabetic Macular Edema (DME)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06116916
Start Date
January 9 2024
End Date
September 30 2026
Last Update
October 30 2025
Active Locations (87)
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1
Barnet Dulaney Perkins Eye Center - Phoenix
Mesa, Arizona, United States, 85206
2
Retina Associates Southwest, P.C.
Tucson, Arizona, United States, 85710
3
Win Retina
Arcadia, California, United States, 91006
4
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211