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

NCT05806957 | Unknown FDA Device

• 1 other identifier: CD0001
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Device: Color Fundus Photography with Non-Mydriatic and Mydriatic Cameras

Device: Fundus Photography

Interventions

Fundus Photography DEVICE

Subjects will undergo Fundus Photography using FDA approved non-mydriatic fundus cameras and mydriatic camera with OCT

Device: Color Fundus Photography with Non-Mydriatic and Mydriatic Cameras

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Aged at least 22 years old.
• 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).
• Willing to undergo fundus photography by up to 4 different methods and/or cameras.
• Has signed a written informed consent form prior to study participation.

You may not qualify if:

• Diagnosed with uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
• Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
• Has a positive history for laser treatment of the retina or injections into either eye, or any history of retinal surgery.
• Is currently participating in another investigational eye study and actively receiving investigational product for DR or Diabetic Macular Edema (DME).
• 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).
• 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

Sponsors & Collaborators

• Ophthalytics, Inc.: lead

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Fluorescein Angiography

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Angiography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Ophthalmological

Central Study Contacts

Joshua Freeman

CONTACT

617 320 4668; josh@ophthalytics.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: June 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 30, 2024
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share