Diabetic RetinopathyAID-DRNCT07236879
Artificial Intelligence for Diagnosing Diabetic Retinopathy in Primary Care
A study testing Mobile retinography interpreted by artificial intelligence and Mobile retinography interpreted by ophthalmologists in people with Diabetic Retinopathy, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This is a clinical trial to evaluate the effects of universal screening for diabetic retinopathy (DR) and diabetic macular edema (DME) using artificial intelligence (AI) in the interpretation of fundus photographs obtained by trained nursing assistant using a portable fundus camera in a primary care setting, compared… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Mobile retinography interpreted by artificial intelligence and Mobile retinography interpreted by ophthalmologists
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 922 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Aug 2024to Dec 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (> 18 years old) diagnosed with diabetes mellitus who agree to participate in the study.
Who cannot join
- Any contraindication for pharmacological mydriasis (such as knowledge of having closed-angle glaucoma, pregnancy).
- Life expectancy less than 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Beatriz D Schaan, MD, PhD, +55 51 3359-8127, bschaan@hcpa.edu.br
Fernando K Malerbi, MD, PhD
About this study
Official title: Effects of Artificial Intelligence-based Diabetic Retinopathy Screening on Timely Access to Treatment in Individuals With Diabetes
This is a clinical trial to evaluate the effects of universal screening for diabetic retinopathy (DR) and diabetic macular edema (DME) using artificial intelligence (AI) in the interpretation of fundus photographs obtained by trained nursing assistant using a portable fundus camera in a primary care setting, compared with images obtained by the same method, but interpreted by ophthalmologists.
- Conditions
- Diabetic Retinopathy
- Being tested
- Mobile retinography interpreted by artificial intelligence, Mobile retinography interpreted by ophthalmologists
- Keywords
- screening, diabetic retinopathy, artificial intelligence
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile retinography interpreted by artificial intelligenceDiagnostic test
All participants will undergo mobile retinal photography in primary care by a trained nursing assistant. If randomized to RDIA group, their photos will be analyzed by artificial intelligence.
Mobile retinography interpreted by ophthalmologistsDiagnostic test
All participants will undergo mobile retinal photography in primary care by a trained nursing assistant. If randomized to RDOF group, their photos will be interpreted remotely by ophthalmologists.
| Study group | Role | What they receive |
|---|---|---|
| RDIA group | Experimental | The proposed intervention is the provision of universal screening for DR with retinography performed on a mobile fundus camera under mydriasis supported by a computer program in adults with diabetes mellitus; based on the diagnosis made by the computer program, patients will be classified as having referable DR or not, and referral to a specialist will be based on this classification. Receives: Diagnostic Test: Mobile retinography interpreted by artificial intelligence |
| RDOF group | Active comparator | The proposed control is the provision of universal screening for DR in adults with diabetes mellitus with retinography performed on a mobile fundus camera under mydriasis and with obtained images being interpreted remotely by ophthalmologists; based on the diagnosis made by the ophthalmologist, patients will be classified as having referable DR or not, and referral to a specialist will be based on this classification. Receives: Diagnostic Test: Mobile retinography interpreted by ophthalmologists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of appropriate referrals to ophthalmologist
Appropriate referrals: asymptomatic patients with moderate to severe nonproliferative DR, proliferative DR, significant macular edema, and uninterpretable exams. This data will be obtained by reviewing the medical records of ophthalmological in-person consults of included patients.
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Number of patients referred for laser sessions
Considering only patients referred for argon laser sessions aiming retinal photocoagulation for the treatment of diabetic retinopathy. This data will be obtained through access to the medical records of patients referred for specialized care.
Measured: Through study completion, an average of 1 year
Number of pharmacological intraocular treatment
Considering treatment with anti-VEGF drugs or intravitreal corticosteroids for the treatment of diabetic retinopathy and diabetic macular edema. This data will be obtained through access to the medical records of patients referred for specialized care.
Measured: Through study completion, an average of 1 year
Referral failure
Screening with false negative result. This data will be obtained by an independent ophthalmologist review of all images of the not referred patients.
Measured: After study completion, an average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start8 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The AID-DR trial is designed as a randomized, controlled, double-blinded, non-inferiority trial with two parallel groups and a primary endpoint of adequate referrals to specialized care. Randomization will be performed in a 1:1 ratio using variable block sizes.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 922 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, TelessaúdeRS / UFRGS
- Responsible party
- Sponsor
- Investigators
- Beatriz D Schaan, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236879
- Sponsor's protocol ID
- 2024-0238
- Acronym
- AID-DR
- Status last verified
- Nov 2025
- First submitted
- 4 Jun 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chagas TA, Dos Reis MA, Leivas G, Santos LP, Gossenheimer AN, Melo GB, Malerbi FK, Schaan BD. Prevalence of diabetic retinopathy in Brazil: a systematic review with meta-analysis. Diabetol Metab Syndr. 2023 Mar 2;15(1):34. doi: 10.1186/s13098-023-01003-2.
PubMed 36864478Schneiders J, Telo GH, Lavinsky D, Dos Reis MA, Correa BG, Schaan BD. Organizational intervention to improve access to retinopathy screening for patients with diabetes mellitus: health care service improvement project in a tertiary public hospital. Prim Care Diabetes. 2023 Aug;17(4):354-358. doi: 10.1016/j.pcd.2023.05.007. Epub 2023 Jun 14.
PubMed 37328386Dos Reis MA, Kunas CA, da Silva Araujo T, Schneiders J, de Azevedo PB, Nakayama LF, Rados DRV, Umpierre RN, Berwanger O, Lavinsky D, Malerbi FK, Navaux POA, Schaan BD. Advancing healthcare with artificial intelligence: diagnostic accuracy of machine learning algorithm in diagnosis of diabetic retinopathy in the Brazilian population. Diabetol Metab Syndr. 2024 Aug 29;16(1):209. doi: 10.1186/s13098-024-01447-0.
PubMed 39210394
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Artificial Intelligence-based Diabetic Retinopathy Screening on Timely Access to Treatment in Individuals With Diabetes
- ClinicalTrials.gov ID
- NCT07236879
- Acronym / sponsor ID
- AID-DR / 2024-0238
- Conditions
- Diabetic Retinopathy
- Keywords
- screening, diabetic retinopathy, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 922 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, TelessaúdeRS / UFRGS
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Nov 2025 (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.
This is a clinical trial to evaluate the effects of universal screening for diabetic retinopathy (DR) and diabetic macular edema (DME) using artificial intelligence (AI) in the interpretation of fundus photographs obtained by trained nursing assistant using a portable fundus camera in a primary care setting, compared with images obtained by the same method, but interpreted by ophthalmologists.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The AID-DR trial is designed as a randomized, controlled, double-blinded, non-inferiority trial with two parallel groups and a primary endpoint of adequate referrals to specialized care. Randomization will be performed in a 1:1 ratio using variable block sizes.
| Arm | Type | Receives |
|---|---|---|
| RDIA group | Experimental | Diagnostic Test: Mobile retinography interpreted by artificial intelligenceThe proposed intervention is the provision of universal screening for DR with retinography performed on a mobile fundus camera under mydriasis supported by a computer program in adults with diabetes mellitus; based on the diagnosis made by the computer program, patients will be classified as having referable DR or not, and referral to a specialist will be based on this classification. |
| RDOF group | Active comparator | Diagnostic Test: Mobile retinography interpreted by ophthalmologistsThe proposed control is the provision of universal screening for DR in adults with diabetes mellitus with retinography performed on a mobile fundus camera under mydriasis and with obtained images being interpreted remotely by ophthalmologists; based on the diagnosis made by the ophthalmologist, patients will be classified as having referable DR or not, and referral to a specialist will be based on this classification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (> 18 years old) diagnosed with diabetes mellitus who agree to participate in the study.
Key exclusion criteria (2 listed)
- Any contraindication for pharmacological mydriasis (such as knowledge of having closed-angle glaucoma, pregnancy).
- Life expectancy less than 6 months
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 |
|---|---|---|
| Mobile retinography interpreted by artificial intelligenceAll participants will undergo mobile retinal photography in primary care by a trained nursing assistant. If randomized to RDIA group, their photos will be analyzed by artificial intelligence. | Diagnostic test | RDIA group |
| Mobile retinography interpreted by ophthalmologistsAll participants will undergo mobile retinal photography in primary care by a trained nursing assistant. If randomized to RDOF group, their photos will be interpreted remotely by ophthalmologists. | Diagnostic test | RDOF group |
Primary outcome
Number of appropriate referrals to ophthalmologist
Time frame: Through study completion, an average of 1 year
Appropriate referrals: asymptomatic patients with moderate to severe nonproliferative DR, proliferative DR, significant macular edema, and uninterpretable exams. This data will be obtained by reviewing the medical records of ophthalmological in-person consults of included patients.
3 secondary outcomes
Number of patients referred for laser sessions
Time frame: Through study completion, an average of 1 year
Number of pharmacological intraocular treatment
Time frame: Through study completion, an average of 1 year
Referral failure
Time frame: After study completion, an average of 15 months
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 19 Nov 2025.
- Background: PubMed 36864478Chagas TA, Dos Reis MA, Leivas G, Santos LP, Gossenheimer AN, Melo GB, Malerbi FK, Schaan BD. Prevalence of diabetic retinopathy in Brazil: a systematic review with meta-analysis. Diabetol Metab Syndr. 2023 Mar 2;15(1):34. doi: 10.1186/s13098-023-01003-2.
- Background: PubMed 37328386Schneiders J, Telo GH, Lavinsky D, Dos Reis MA, Correa BG, Schaan BD. Organizational intervention to improve access to retinopathy screening for patients with diabetes mellitus: health care service improvement project in a tertiary public hospital. Prim Care Diabetes. 2023 Aug;17(4):354-358. doi: 10.1016/j.pcd.2023.05.007. Epub 2023 Jun 14.
- Background: PubMed 39210394Dos Reis MA, Kunas CA, da Silva Araujo T, Schneiders J, de Azevedo PB, Nakayama LF, Rados DRV, Umpierre RN, Berwanger O, Lavinsky D, Malerbi FK, Navaux POA, Schaan BD. Advancing healthcare with artificial intelligence: diagnostic accuracy of machine learning algorithm in diagnosis of diabetic retinopathy in the Brazilian population. Diabetol Metab Syndr. 2024 Aug 29;16(1):209. doi: 10.1186/s13098-024-01447-0.
- Individual participant dataSharing planned: No
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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.
Beatriz D Schaan, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile retinography interpreted by artificial intelligence and Mobile retinography interpreted by ophthalmologists in people with Diabetic Retinopathy, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 2 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Beatriz D Schaan, MD, PhD (+55 51 3359-8127, bschaan@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of appropriate referrals to ophthalmologist (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07236879, which also lists 3 linked publications.
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 19 Nov 2025.