JPRN-jRCT2032220358CompletedPhase 3
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 enrollmentStarted: October 4, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 275
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •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)
Exclusion Criteria
- •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).
Investigators
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