Diabetic RetinopathyNCT04794907
Retinal Care Data Repository
An observational study of Diabetic Retinopathy and Age Related Macular Degeneration, run by Retinal Care Inc..
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. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Diabetic Retinopathy, Age Related Macular Degeneration
- What is being tested?
- Observation
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2022to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 100 years
- All sexes
- Child, Adult, Older adult
Study population: The DR cohort includes any patient with diabetes. The AMD cohort includes patients 55 years and older.
Who may be able to join
- Diabetes or age 65 years and older
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Being tested
- Observation
- Medical subject headings
- Diabetic Retinopathy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Patient data will be collected from eye exams, surveys and medical record review.
| Study group | Role | What they receive |
|---|---|---|
| DR | Patients with diabetes Receives: Other: Observation | |
| AMD | Patients age 55 and older Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Stratification
Predict the participant's risk of developing specific severity levels of DR and AMD
Measured: Decade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start31 Dec 2022 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retinal Care Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen R Fransen, Principal investigator, Retinal Care Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794907
- Sponsor's protocol ID
- 10-PLN-003
- Status last verified
- Oct 2022
- First submitted
- 9 Mar 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Care Data Repository
- ClinicalTrials.gov ID
- NCT04794907
- Acronym / sponsor ID
- 10-PLN-003
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Retinal Care Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2022 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DR | – | Other: ObservationPatients with diabetes |
| AMD | – | Other: ObservationPatients age 55 and older |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The DR cohort includes any patient with diabetes. The AMD cohort includes patients 55 years and older.
Key inclusion criteria (1 listed)
- Diabetes or age 65 years and older
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationPatient data will be collected from eye exams, surveys and medical record review. | Other | AMD, DR |
Primary outcome
Risk Stratification
Time frame: Decade
Predict the participant's risk of developing specific severity levels of DR and AMD
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen R Fransen principal investigator
Retinal Care Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy and Age Related Macular Degeneration, run by Retinal Care Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen R Fransen, MD (4052097531, stephen.fransen@retinalcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Stratification (time frame: Decade). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.