Overview

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

Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kyowa Kirin, Inc.
Treatments:
Aflibercept
Criteria
Inclusion Criteria:

- Voluntary written informed consent to participate in the study

- BCVA ETDRS letter score of 73 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

- Previous use of periocular or intraocular (sub-Tenon or IVT) corticosteroids

- Previous intraocular device implantation except PC-IOL

- Previous laser (any type) to the macular area

- Previous panretinal photocoagulation treatment

- Previous treatment with any IVT anti-VEGF drugs

- 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