Pivotal Trial to Assess the Clinical Performance of Ophthal-360 for the Detection of Diabetic Retinopathy

Pivotal Trial to Assess the Clinical Performance of Ophthal-360

Multicenter, prospective, study to assess the performance of the Ophthal-360 platform in the diagnosis of more-than-mild Diabetic Retinopathy (mtmDR) in diabetic patients with no previous diagnosis of DR.

This is a multicenter, prospective study in which 500 adult subjects at risk for DR but never before diagnosed who satisfy all entry criteria will be enrolled at up to 5 primary care sites.

An additional sub-study will be performed on 30 subjects to assess the precision of the algorithm in detecting DR by imaging these subjects multiple times to demonstrate intra- and inter-operator reliability of the algorithm.

All enrolled subjects will undergo retinal imaging by a novice operator with no experience using the fundus cameras listed. Images from each retinal imaging device will be saved to a computer and uploaded to the server for evaluation by the Ophthal-360 service. A report will be generated and archived for the results of each image.

After imaging by the novice operator, each patient will then have their eyes photographed by a professional fundus photographer using standard mydriatic and OCT imaging for macular edema evaluation. These images will be sent to a Fundus Photography Reading Center for final determination and diagnosis. Patients will received the result of the FPRC evaluation, but not be provided the reports generated by the software.

A comparison between the FPRC determination and the software generated report will be performed to evaluate the analytical performance of the algorithm.

Inclusion Criteria:

1. Aged at least 22 years old.

2. A documented history of Diabetes Mellitus, defined as any of the following:

   • Hemoglobin A1c (HbA1c) ≥ 6.5% based on repeated assessments
   • Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) based on repeated assessments
   • Oral Glucose Tolerance test with 2-hour plasma glucose ≥ 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water.
   • Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose ≥ 200mg/dL (11.1 mmol/L)
   • Criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA).

3. Willing to undergo fundus photography by up to 4 different methods and/or cameras.

4. Has signed a written informed consent form prior to study participation.

Exclusion Criteria:

1. Diagnosed with uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.

2. Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.

3. Has a positive history for laser treatment of the retina or injections into either eye, or any history of retinal surgery.

4. Is currently participating in another investigational eye study and actively receiving investigational product for DR or Diabetic Macular Edema (DME).

5. 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).

6. Is contraindicated for imaging by fundus imaging systems used in the study:

   • hypersensitive to light
   • recently (within 6 months) underwent photodynamic therapy (PDT)
   • taking medication that causes photosensitivity
   • positive history for angle-closure glaucoma or narrow anterior chamber angles