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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Study Summary
The goal of this prospective study is to evaluate device performance when using fundus images taken from retinal fundus cameras in subjects with and without diabetic retinopathy per ETDRS level 35 and higher with or without macular edema.
Eligible Conditions
- Diabetic Macular Edema
- Diabetic Retinopathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Objective
Other outcome measures
Exploratory Endpoint
Exploratory Objective
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Subjects with ETDRS 20 or less and no DME
Group II: Group 1Experimental Treatment1 Intervention
Subjects with ETDRS ≥ 35 with or without DME
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Who is running the clinical trial?
Digital Diagnostics, Inc.Lead Sponsor
4 Previous Clinical Trials
3,058 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
3,058 Patients Enrolled for Diabetic Retinopathy
Audrey Singh, BSStudy DirectorDigital Diagnostics, Inc.
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