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The primary endpoint is usually improvement in visible acuity , defined by responder status, in comparison to placebo. Following washout and treatment, patients will end up being assessed for vision regression and a 12 week open label extension study will be offered to evaluate the duration of aftereffect of the optimal dose.. Ampio Pharmaceuticals begins Optina clinical trial Ampio Pharmaceuticals, Inc. announced oral dosing of the first patient in a 505 medical trial of the investigational drug Optina in diabetic macular edema. A complete of 450 individuals are expected to enroll.5mg per BMI and 1.0mg per BMI per day) or placebo. Following the 12 week active treatment period, you will have a further 4 week washout period to determine regression of treatment effect.