- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04774822
Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device
Study Overview
Status
Intervention / Treatment
Detailed Description
This study is a prospective, multicenter, observational study to assess the safety and efficacy of RETINA-AI Galaxy in screening for diabetic retinopathy in the primary care setting. The study design conforms to an Intent to Screen (ITS) paradigm [1]. The Galaxy is a software medical device designed to analyze digital color fundus photographs and rapidly screen for the presence of more than mild diabetic retinopathy or vision-threatening diabetic retinopathy in the primary care setting.
The study will enroll 360 subjects after exclusions. Subjects who meet eligibility criteria will be recruited from three sites staffed by primary care providers. Eligibility will be assessed and informed consent obtained, after which digital color fundus photographs will be taken using U.S. Food and Drug Administration (FDA) cleared non-mydriatic fundus cameras, by an operator using the Galaxy photography manual.
There will be a total of 5 non-mydriatic robotic screening cameras used in the AI system protocol part of the study. There will be a dedicated validation camera used in the Validation Reading Center Protocol part of the study. Primary care clinical staff (e.g. medical assistant) with no prior professional ophthalmic photography experience and only a 4 hour training will operate the RETINA-AI Galaxy device and the screening cameras. The Retina Reading Center - certified professional ophthalmic photographers will operate the validation fundus cameras according the the 4W-D stereo protocol.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Texas
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Houston, Texas, United States, 77043
- Biopharma Informatic, Llc
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Houston, Texas, United States, 77074
- Clinical Trial Network
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Houston, Texas, United States, 77084
- Biopharma Informatic LLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient age 22 or above
Patient with documented diagnosis of diabetes as defined by:
A. Hemoglobin A1c (HbA1c)>= 6.5% based on repeated assessments
B. Fasting Plasma Glucose (FPG) >= 126 mg/dL (7.0 mmol/L) based on repeated assessments
C. Oral Glucose Tolerance test with 2 hr plasma glucose >= 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water.
D. Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose >=200mg/dL (11.1 mmol/L)
E. Per World Health Organization (WHO) or American Diabetes Association diabetes criteria
- Understanding of the Study and willingness and ability to sign informed consent
Exclusion Criteria:
- Persistent vision loss in one or both eyes
- Diagnosis with macula edema, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, radiation retinopathy, or retinal vein occlusion
- History of retinal laser treatment or intraocular injections of other eye; or any prior history of retinal surgery.
- Current enrolled in another interventional study of an investigational device or drug and actively receiving investigational product for DR or DME
- Subject has a condition that in the principal investigator's opinion would preclude participation in the study (e.g it may confound study results or result in ungradable photographs for clinical reference standard)
- Subject has contraindication to mydriatic agent (dilating drops) or is unwilling or unable to dilate
- Subject is contraindicated from fungus photography (e.g. subject is hypersensitivity to light).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Sequential Enrollment
Enrollment based on default inclusion criteria listed below
|
Stereoscopic Fundus photography
Eye dilating agent
Optical Tomographic imaging of retina
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Enrichment Enrollment
Enrollment based periodic statistician-activated inclusion criteria adjustment to attain statistically adequate distribution
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Stereoscopic Fundus photography
Eye dilating agent
Optical Tomographic imaging of retina
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the sensitivity and specificity of RETINA-AI Galaxy to detect more than mild diabetic retinopathy in the primary care setting
Time Frame: 1 visit (1 day)
|
To determine the sensitivity and specificity of RETINA-AI Galaxy for detecting more than mild diabetic retinopathy (mtmDR) defined as moderate non-proliferative diabetic retinopathy, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, or clinically significant diabetic macula edema.
|
1 visit (1 day)
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To determine the sensitivity and specificity of RETINA-AI Galaxy to detect vision-threatening diabetic retinopathy in the primary care setting
Time Frame: 1 visit (1 day)
|
To determine the sensitivity and specificity of RETINA-AI Galaxy for detecting vision threatening diabetic retinopathy (vtDR) defined as severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, or clinically significant diabetic macula edema.
|
1 visit (1 day)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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 Degeneration
- Macular Degeneration
- Retinal Diseases
- Diabetic Retinopathy
- Macular Edema
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Mydriatics
Other Study ID Numbers
- RETINA-AI-CT1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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