A Multicenter Study to Evaluate Safety and Efficacy and Usefulness of DDX-01 which Supports Screening for Diabetic Retinopathy and Diabetic Macular Edema in Internal Medicine for Japanese Patients with Diabetes Mellitus

Tomita Koji0 sites275 target enrollmentOctober 4, 2022

ConditionsDiabetis

Overview

No summary available.

Registry

who.int

Start Date

October 4, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Tomita Koji

•1\. Japanese ancestry who understands the study and volunteer to sign the informed consent
•2\. Age 18 or older
•3\. Documented diagnosis of diabetes mellitus, per any of the following:
•a. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
•b. Hemoglobin A1c (HbA1c) greater than or equal to 6\.5%
•c. Fasting Plasma Glucose (FPG) greater than or equal to 126 mg/dL (7\.0 mmol/L)
•d. Oral Glucose Tolerance Test (OGTT) with two\-hour plasma glucose (2\-hr PG) greater than or equal to 200 mg/dL (11\.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucose dose dissolved in water
•e. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) greater than or equal to 200 mg/dL (11\.1 mmol/L)

•1\. Persistent vision loss, blurred vision, or floaters.
•2\. Diagnosed with macular edema, severe non\-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
•3\. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
•4\. Subject is contraindicated for imaging by fundus imaging systems used in the study due to any of the following:
•a. Subject is hypersensitive to light
•b. Subject recently underwent photodynamic therapy (PDT)
•c. Subject is taking medication that causes photosensitivity
•5\. Currently participating in another investigational eye study and actively receiving investigational product for Diabetic retinopathy or Diabetic macular edema.
•6\. Subject has a condition that, in the opinion of the Investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).