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NCT04794907 Clinical Trial

Retinal Care Data Repository

Diabetic Retinopathy Clinical Trial

Official title:
Retinal Care Data Repository

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04794907
Other study ID # 10-PLN-003
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 31, 2022
Est. completion date December 2030

Study information
Verified date October 2022
Source Retinal Care Inc.
Contact Stephen R Fransen, MD
Phone 4052097531
Email stephen.fransen@retinalcare.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Retinal Care Data Repository's primary objective is to make data available for Retinal Care to develop algorithms that improve the care of people with retinal diseases.

Description:

The initial focus is to develop algorithms that prevent, delay the progression, or improve treatment of diabetic retinopathy (DR) and age-related macular degeneration (AMD). Examples include but are not limited to: describing the incidence, prevalence, and severity distribution of DR and AMD in the overall population and subgroups; diagnosing specified severity thresholds for DR and AMD; predicting the development and progression of DR and AMD for the overall population, subgroups, and individuals; and recommending tests and treatments to prevent or delay the progression of DR and AMD for the overall population, subgroups, and individuals. Data will be collected retrospectively and prospectively.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date December 2030
Est. primary completion date December 2030
Accepts healthy volunteers
Gender All
Age group 0 Years to 100 Years
Eligibility Inclusion Criteria: - Diabetes or age 65 years and older Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Observation
Patient data will be collected from eye exams, surveys and medical record review.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Retinal Care Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Risk Stratification Predict the participant's risk of developing specific severity levels of DR and AMD Decade
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