4D-150 in Patients With Diabetic Macular Edema

Inclusion Criteria

• •≥18 years of age
• •Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea; diagnosis of DME must be within 2 years of Screening
• •CST ≥ 350 μm (Spectralis SD-OCT) in the study eye at Screening, confirmed by the independent reading center
• •Demonstrate clinical response to on-study aflibercept injection in the study eye.
• •Decreased visual acuity attributable primarily to DME
• •BCVA in the study eye between 25 and 83 ETDRS letters, inclusive (\~20/320 and 20/25, respectively) at Screening
• •Study eye amenable to IVT injection
• •Sufficient clear ocular media, pupil dilation and fixation in the study eye to permit adequate imaging; ability to perform tests of visual and retinal function and structure; and ability to comply with other protocol-specified procedures
• •Provide written informed consent