The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with diabetic macular edema.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
131
Retinal Consultants of Arizona
Phoenix, Arizona, United States
Best-corrected visual acuity by ETDRS
Time frame: 180 days
Foveal central subfield thickness as determined by OCT
Time frame: 180 days
Safety across dose groups versus placebo
Time frame: 180 days
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Two subconjunctival injections of 880 micrograms sirolimus each.