MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema

Inclusion Criteria:

• Diagnosis of diabetes mellitus (type 1 or type 2) according to ADA or WHO diabeticdiagnosis criteria

• Subject has the ability to follow the study instructions and is likely to completeall required study procedures and visits;

• All males and females must consent to pregnancy prevention during the study andqualified measures of birth control. All females of childbearing potential mustconsent to a pregnancy test before entering the study.

• Presence of central involved macular edema associated with diabetic retinopathy,i.e. diabetic macular edema (DME), as assessed by spectral domain optical coherencetomography (sd-OCT) of the central retina subfield thickness (CRT) at the ScreeningVisit (Centration must be confirmed by Investigators with signatures);

• Best Corrected Visual Acuity (BCVA) score ≥ 34 letters (approximately 20/200 to 20/20 Snellen equivalent or better) using the Early Treatment Diabetic RetinopathyStudy (ETDRS) visual acuity protocol, and assessed at the Screening Visit Visualacuity (VA);

• Confirmation by the investigator that laser photocoagulation and anti-VEGFtreatments are either declined by the patients or not needed and can be withheld forat least 3 months after the Screening Visit;

• Ocular media and pupil dilation adequate to permit good quality retinal imaging asassessed at Screening Visit.

Exclusion Criteria:

• Subjects with unstable metabolic or blood pressure control

• Subject with emaciation or obesity at Screening Visit: body mass index (BMI) <18.5kg/m2 or >28kg/m2

• Current use or likely need for medications know to be toxic to the lens, retina oroptic nerve, including Deferoxamine, Chloroquine / hydroxychloroquine (Plaquenil),Tamoxifen, Phenothiazines and Ethambutol -

• History of myocardial infarction or other cardiac event requiring hospitalization (unstable angina pectoris, etc.), cerebrovascular accident, transient ischemicattack, treatment for acute congestive heart failure or any arrhythmia within 4-months prior to Screening Visit;

• Any situation that may in the opinion of the investigator preclude the safeadministration of the study medication, adherence to the scheduled study visits,safe participation in the study or affect the results of the study as assessed atScreening Visit;