This study is an interventional, prospective randomized study comparing the dexamethasone
implant to intravitreal aflibercept. Subjects will have an initial single injection of
aflibercept and will be randomized if diabetic macular edema persists. Each subject will be
evaluated for 6 months following randomization. Thus, the study duration will be 12 months
plus the recruitment period.
Subjects will be evaluated every month for safety, efficacy as measured by SDOCT and best
corrected visual acuity (BCVA) using the Electronic Early Treatment Diabetic Retinopathy
Study (E-ETDRS) protocol. In addition, ultra-widefield angiography will be performed at
run-in visit, baseline, month 3, and month 6.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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