Status and phase
Conditions
Treatments
About
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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
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
Primary purpose
Allocation
Interventional model
Masking
150 participants in 3 patient groups
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Central trial contact
Kyowa Kirin, Inc.
Data sourced from clinicaltrials.gov
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