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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Device: Fundus Photography

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Joshua Freeman; Phone Number: 617 320 4668; Email: josh@ophthalytics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults diagnosed with diabetes at risk for diabetic retinopathy but not previously diagnosed.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Device: Color Fundus Photography with Non-Mydriatic and Mydriatic Cameras	Device: Fundus Photography; Subjects will undergo Fundus Photography using FDA approved non-mydriatic fundus cameras and mydriatic camera with OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the Ophthal-360 Software to detect diabetic retinopathy in fundus images	Performance of the Ophthal-360 Software when compared to results of evaluation of fundus photographs by qualified experts.	1 day
Specificity of the Ophthal-360 Software to detect diabetic retinopathy in fundus images	Performance of the Ophthal-360 Software when compared to ground truth evaluation of fundus photographs by qualified experts.	1 day

Collaborators and Investigators

• Sponsor: Ophthalytics, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: CD0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No