Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device

• ClinicalTrials.gov Identifier: NCT04774822
• Recruitment Status: Completed
• First Posted: March 1, 2021
• Last Update Posted: September 16, 2021
• Sponsor: RETINA-AI Health, Inc.
• Information provided by (Responsible Party): RETINA-AI Health, Inc.

Study Description

Brief Summary:

Diabetes affects approximately 35 million Americans, each of whom needs at least one retinal exam per year. However, majority do not get their eye exam due to multiple prohibitive factors such as cost, transportation, difficulty of taking time off from work, and inconvenience, amongst others. The standard of care in diabetes requires at least an annual eye exam to detect onset of diabetic retinopathy and to treat when indicated. This is important as diabetes is the most common cause of visual impairment and blindness in working age adults in the United States. There are too few trained professionals to diagnose diabetic retinopathy, this prompted the development of RETINA-AI Galaxy an automated software as a medical device which screens for diabetic retinopathy in the primary care setting. This observational study is designed to validate the safety and efficacy of the device.

Condition or disease	Intervention/treatment
Diabetic Retinopathy; Diabetic Eye Problems; Diabetic Macular Edema	Procedure: Color Fundus Photography; Drug: Mydriatics Agent; Procedure: Optical Coherence Tomography (OCT)

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 Design

• Study Type: Observational
• Actual Enrollment: 397 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device
• Actual Study Start Date: March 25, 2021
• Actual Primary Completion Date: May 28, 2021
• Actual Study Completion Date: August 31, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Sequential Enrollment; Enrollment based on default inclusion criteria listed below	Procedure: Color Fundus Photography; Stereoscopic Fundus photography; Drug: Mydriatics Agent; Eye dilating agent; Procedure: Optical Coherence Tomography (OCT); Optical Tomographic imaging of retina
Enrichment Enrollment; Enrollment based periodic statistician-activated inclusion criteria adjustment to attain statistically adequate distribution	Procedure: Color Fundus Photography; Stereoscopic Fundus photography; Drug: Mydriatics Agent; Eye dilating agent; Procedure: Optical Coherence Tomography (OCT); Optical Tomographic imaging of retina

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 22 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Study subjects from Primary Care clinics - sampling method: non-probability, invitation to volunteer

Criteria

Inclusion Criteria:

1. Patient age 22 or above

2. 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

3. Understanding of the Study and willingness and ability to sign informed consent

Exclusion Criteria:

1. Persistent vision loss in one or both eyes
2. Diagnosis with macula edema, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, radiation retinopathy, or retinal vein occlusion
3. History of retinal laser treatment or intraocular injections of other eye; or any prior history of retinal surgery.
4. Current enrolled in another interventional study of an investigational device or drug and actively receiving investigational product for DR or DME
5. 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)
6. Subject has contraindication to mydriatic agent (dilating drops) or is unwilling or unable to dilate
7. Subject is contraindicated from fungus photography (e.g. subject is hypersensitivity to light).

Contacts and Locations

Locations

United States, Texas

Biopharma Informatic, LLC

Houston, Texas, United States, 77043

Clinical Trial Network

Houston, Texas, United States, 77074

Biopharma Informatic LLC

Houston, Texas, United States, 77084

Sponsors and Collaborators

RETINA-AI Health, Inc.

More Information

• Responsible Party: RETINA-AI Health, Inc.
• ClinicalTrials.gov Identifier: NCT04774822
• Other Study ID Numbers: RETINA-AI-CT1
• First Posted: March 1, 2021
• Last Update Posted: September 16, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Macular Edema; Retinal Diseases; Diabetic Retinopathy; Macular Degeneration; Retinal Degeneration; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Mydriatics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs