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History of Changes for Study: NCT02963441
A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy
Latest version (submitted May 5, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 14, 2016 None (earliest Version on record)
2 December 21, 2016 Recruitment Status and Study Status
3 January 15, 2018 Recruitment Status, Study Status, Study Design
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Results Submission Events
4 May 5, 2021 Study Status, Outcome Measures, Study Description, Document Section, Results and Eligibility
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Study NCT02963441
Submitted Date:  November 14, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: IDx-DR1
Brief Title: A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy
Official Title: A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2016
Overall Status: Not yet recruiting
Study Start: November 2016
Primary Completion: June 2017 [Anticipated]
Study Completion: August 2017 [Anticipated]
First Submitted: November 10, 2016
First Submitted that
Met QC Criteria:
November 14, 2016
First Posted: November 15, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 14, 2016
Last Update Posted: November 15, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: IDx LLC
Responsible Party: Sponsor
Collaborators: The Emmes Company, LLC
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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 Description:

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 requirements of the sponsor and the CRO, will be notified in writing of the deficiencies and permitted a reasonable opportunity to rectify deficient conditions. After study initiation, the inability of the site to rectify seriously deficient conditions in a timely manner or to maintain compliance with regulatory requirements may be cause for termination of study activities, closure of the investigational site, and notification of that decision to the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) and other regulatory authorities as appropriate.

Participating sites will have an initial monitoring visit, routine interim monitoring visits (at a schedule determined by sponsor or CRO) during the study and a study close-out visit conducted by experienced monitoring personnel. Additional monitoring visits may be performed for cause or if the volume of information to be reviewed cannot be easily completed in a single visit. Study visits will normally be scheduled well in advance so that necessary site staff and appropriate records will be available during the monitoring visit.

Each monitoring visit will utilize a standardized checklist of elements to be reviewed at the site, tailored to the specific requirements of this study. Site monitoring visits will routinely review the participating site staff roster; study administrative and financial documents; required regulatory documentation; status of IRB/IEC approvals; changes or actions taken since any previous visit; participant recruitment status, screening, enrollment, and follow-up visit records; documentation of informed consent for each participant; review of adverse events; investigational product storage conditions; outstanding data clarifications and a review of data elements against source documentation. Site visits will follow standard CRO procedures and a report will be prepared for study records.

The CRO will host and manage a web-based integrated clinical data system in compliance with FDA's guidance on Computerized Systems Used in Clinical Investigations (2007) and 21 CFR Part 11. The CRO will also develop and implement standard web-based electronic Case Report Forms (eCRFs) used by the clinical trial sites and the image reading center. Quality assurance and selected data integrity controls will be built into each eCRF, and the CRO may apply additional data integrity checks to assist in monitoring and improving data quality. The CRO will obtain IDx-DR results directly from the computer server system that is isolated from sponsor access during and after the study until the analyses are completed according to the SAP.

The Sponsor has chosen an independent data storage center for the clinical trial. The IDx-DR software will be locked prior to initiating the clinical trial. A copy will be placed in escrow prior to the start of enrollment for auditing purposes.

Documentation, logging and audited records will provide evidence that IDx does not have direct access to any trial data during the course of the trial.

Safety will be evaluated during the time the participant is in the study which will include from the time of consent through the time of exit which will typically be less than one day. Safety will be assessed by frequency and incidence of ADEs and UADEs.

Because this is considered a device study, it is consistent to use the following definitions when assessing safety issues:

  • Adverse device effect (ADE), which means an adverse event related to the use of an investigational medical device.
  • Unanticipated adverse device effect (UADE), which means any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with its use that had not been previously identified in nature, severity, or degree of incidence.

The CRO will provide safety reporting services, including review, assessment, documentation, and reporting of AEs or UADEs submitted by clinical investigators. Investigators and the Sponsor will be notified if unreported AEs or UADEs are observed in study records by the monitors during routine or for cause monitoring activities.

Events considered serious and unexpected by the site staff or the CRO will be immediately investigated by the CRO or Sponsor to determine if the event qualifies for expedited reporting to regulatory authorities. The CRO will be responsible for coordinating the expedited reporting of serious and unexpected AEs or UADEs to regulatory authorities within the required timeframes once the determination for reporting has been made. The CRO will review summary information on all reports of unexpected serious AEs or UADEs submitted by investigators, and will review individual events if the situation requires.

Open or close this module Conditions
Conditions: Diabetic Retinopathy
Keywords: Diabetic Retinopathy
Macular Edema
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Only
Time Perspective: Cross-Sectional
Biospecimen Retention:
Biospecimen Description:
Enrollment: 834 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. To determine the sensitivity and specificity of IDx-DR to diabetic retinopathy in the primary care setting
[ Time Frame: Day 1 ]

Open or close this module Eligibility
Study Population: Primary care clinic - sampling method: non-probability, invitation to volunteer
Sampling Method: Non-Probability Sample
Minimum Age: 22 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Documented diagnosis of diabetes mellitus, e.g.:
    1. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
    2. Hemoglobin A1c (HbA1c) ≥ 6.5%
    3. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
    4. Oral Glucose Tolerance Test (OGTT) with two-hour plasma glucose (2-hr PG) ≥ 200 mg/dL (11.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucose dose dissolved in water
    5. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
  2. Age 22 or older
  3. Understand the study and volunteer to sign the informed consent

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. Currently participating in another investigational eye study and actively receiving investigational product for DR or DME.
  5. Participant 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. Participant is contraindicated for imaging by fundus imaging systems used in the study:
    • Participant is hypersensitive to light
    • Participant recently underwent photodynamic therapy (PDT)
    • Participant is taking medication that causes photosensitivity
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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