Clinical Trial: A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational
Official Title: A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy
Brief Summary:
Diabetes affects 29.1 million people or 9.3% of the population of the United States. Results of a study by the Eye Diseases Prevalence Research Group reveal that 40% of diabetes patients have some degree of diabetic retinopathy (DR) and that as many as 8% have severe, vision-threatening forms of DR. Early laser photocoagulation in high-risk proliferative diabetic retinopathy (PDR) has been shown to decrease the relative risk of vision loss by as much as 52%. Injections of anti-VEGF agents preserve and improve vision in people with PDR and/or diabetic macular edema. Despite effective treatment however, tens of thousands of people with diabetes are going blind each year largely because they don't undergo annual screening for retinopathy. Currently, only some 50%-60% of people with diabetes have a yearly eye exam and there may not be enough eye specialists to see the balance.
To address the issue of patient compliance with diabetic retinopathy screening, IDx-DR was developed as an automated screening device designed to analyze fundus images for the presence of lesions and other disease features associated with diabetic retinopathy. This study has been designed to validate the safety and efficacy of the device at the frontlines of healthcare.
Detailed Summary:
The study is a multicenter observational study with primary endpoints to determine the sensitivity and specificity of IDx-DR to diabetic retinopathy in the primary care setting. IDx-DR is an automated software device that is designed to analyze ocular fundus digital color photographs taken in frontline primary care settings in order to quickly screen for diabetic retinopathy (DR).
The study will involve 834 subjects after exclusions. Participants who meet the eligibility criteria will be recruited from sites staffed by primary care providers. After assessing eligibility and securing written informed consent, fundus photographs will be captured using a commercially available, Food and Drug Administration (FDA) cleared, non-mydriatic ocular fundus camera by a camera operator who does not have previous professional experience in ophthalmic photography. Images will be taken according to a specific IDx-DR imaging protocol provided to the camera operator and then analyzed by the IDx-DR device.
The photography protocol consists of two images of the ocular fundus (one optic disc centered, one macula centered), obtained from both eyes of enrolled participants. After generating an IDx-DR screening result, professional ophthalmic photographer will perform gold standard imaging for reference standard grading and determination of the sensitivity and specificity of the IDx-DR device.
The CRO will follow standard operating procedures for monitoring this study in accordance with Good Clinical Practice (GCP) recommendations and FDA regulatory requirements. Any site not meeting the minimum requirements to initiate the trial, or that has administrative, procedural or data quality deficiencies that require correction in order to comply with regulatory requirements, the protocol, or to meet the
Sponsor: IDx LLC
Current Primary Outcome: To determine the sensitivity and specificity of IDx-DR to diabetic retinopathy in the primary care setting [ Time Frame: Day 1 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: IDx LLC
Dates:
Date Received: November 10, 2016
Date Started: November 2016
Date Completion: August 2017
Last Updated: December 21, 2016
Last Verified: December 2016
