NCT04794907

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Dec 2022

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Dec 2022Dec 2030

First Submitted

Initial submission to the registry

March 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 31, 2022

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

7.9 years

First QC Date

March 9, 2021

Last Update Submit

October 24, 2022

Conditions

Diabetic RetinopathyAge Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Risk Stratification

    Predict the participant's risk of developing specific severity levels of DR and AMD

    Decade

Study Arms (2)

DR

Patients with diabetes

Other: Observation

AMD

Patients age 55 and older

Other: Observation

Interventions

ObservationOTHER

Patient data will be collected from eye exams, surveys and medical record review.

AMDDR

Eligibility Criteria

Age0 Years - 100 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The DR cohort includes any patient with diabetes. The AMD cohort includes patients 55 years and older.

You may qualify if:

  • Diabetes or age 65 years and older

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic RetinopathyMacular Degeneration

Interventions

Observation

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesRetinal Degeneration

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Stephen R Fransen

    Retinal Care Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen R Fransen, MD

CONTACT

4052097531stephen.fransen@retinalcare.com

Landon R Grace, PhD

CONTACT

4053066474landon.grace@retinalcare.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 12, 2021

Study Start

December 31, 2022

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

October 26, 2022

Record last verified: 2022-10