Retinal Care Data Repository | NCT04794907

Studies
Retinal Care Data Repository

NCT04794907

Sponsor

Retinal Care Inc.

Status

Not yet recruiting

Last Update Posted

Oct 26, 2022Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Diabetic Retinopathy
Age Related Macular Degeneration

Interventions

Observation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2022Estimated

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Mar 9, 2021

First Submission Date that Met QC Criteria

Mar 9, 2021

First Posted Date

Mar 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2022

Last Update Posted Date

Oct 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DR		Patients with diabetes	Other: Observation
AMD		Patients age 55 and older	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	Patient data will be collected from eye exams, surveys and medical record review.	AMD DR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Risk Stratification	Predict the participant's risk of developing specific severity levels of DR and AMD	Decade

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetes or age 65 years and older

Exclusion Criteria:

None

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stephen R Fransen, MD	Contact	4052097531		stephen.fransen@retinalcare.com
Landon R Grace, PhD	Contact	4053066474		landon.grace@retinalcare.com

Overall Officials

Name	Affiliation	Role
Stephen R Fransen	Retinal Care Inc.	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided