A Phase 2, Multicenter, Randomized, Double-Masked, Parallel-Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients With Diabetic Macular Edema
A Phase 2, Multicenter, Randomized, Double-Masked, Parallel-Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients With Diabetic Macular Edema
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
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
St. Petersburg, Florida 33711, United States
Charleston, South Carolina 29414, United States
Austin, Texas 78705, United States
Kita-gun, Kagawa-ken 761-0793, Japan