Diabetic RetinopathyALERTNCT07417410
Analysis of DR Progression to Identify Risks and Need for Treatment
An observational study of Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
Trial summary
The goal of this observational study is to understand whether vascular and structural changes in the eyes caused by diabetes can help predict which people are more likely to experience worsening diabetic retinopathy (a diabetes-related eye disease) and how these eye changes are related to cardiovascular complications. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 1,000 participants
- Where
- 1 sitePortugal
- Study dates
- 3 Nov 2025to Nov 2027
- 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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1.000 participants with T2D will be included in this study, in a recruitment period of 12 months.
Who may be able to join
- Diagnosed with type 2 diabetes according to the 1985 WHO criteria.
- Age between 35 and 90 years.
- Retrospective visit or referenced patients. For the retrospective visit, a documented follow-up of 1-5 years is required, with at least one clinical visit. For the referenced patients, it is required that they have either diabetic retinopathy at the baseline visit, the presence of at least one cardiovascular risk factor at the baseline visit, or cardiovascular complications at the baseline visit.
- Signed informed consent.
Who cannot join
- Previous laser photocoagulation or intravitreal injections (consider if corticosteroids were administered).
- Presence of clinically significant macular edema (CSME) with vision loss or requiring immediate treatment.
- Proliferative diabetic retinopathy.
- Any ocular surgery within the previous 3 months.
- Renal Replacement Therapy (Hemodialysis, Peritoneal Dialysis).
- Severe systemic illness, subject to investigator's judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
AIBILI-Clinical Trial Centre
Portugal, Coimbra District, 3000-548
Inês P Marques, MD, PhD, 239480124, ipmarques@aibili.pt
About this study
The goal of this observational study is to understand whether vascular and structural changes in the eyes caused by diabetes can help predict which people are more likely to experience worsening diabetic retinopathy (a diabetes-related eye disease) and how these eye changes are related to cardiovascular complications.
The study will include about 1,000 people with type 2 diabetes, aged 35 to 90 years, and will take place over twelve months. It may also include a retrospective component, where existing medical and imaging data collected from previous visits (within the last 1 to 5 years) will be analyzed.
Read more
The main questions it aims to answer are:
- Can eye vessel and tissue changes, observed through modern imaging techniques and clinical data, help better describe and predict which cases of diabetic retinopathy will become more severe?
- Can these same eye changes help predict the presence and risk of cardiovascular problems-such as heart disease or stroke-in people living with type 2 diabetes?
Read the detailed description
Diabetic Retinopathy (DR) is a leading cause of vision loss in adults with type 2 diabetes (T2D) and is associated with systemic complications, including cardiovascular disease. Early identification of patients at high risk of DR progression and cardiovascular events is critical to optimizing clinical management. Retinal imaging biomarkers, combined with clinical and demographic data, provide an opportunity to better understand disease mechanisms, predict progression of DR and associated cardiovascular complications, and guide personalized interventions.
The aim of this study is to investigate the influence of central versus peripheral retinal lesions on DR progression and staging, characterize associations between retinal biomarkers and cardiovascular risk factors and major adverse cardiovascular events (MACE), and contribute to the understanding of pathophysiological mechanisms underlying DR in T2D patients. The study will also generate a high-quality, harmonized database to support the development of artificial intelligence (AI) models.
This study aims to determine the extent to which central and peripheral retinal lesions, together with quantitative imaging biomarkers, contribute to the progression and staging of DR and the occurrence of cardiovascular complications in patients with T2D. Additionally, in the scope of the ALERT project (supported by Fundação para Ciência e Tecnologia (FCT); COMPETE2030-FEDER-00921900), the data of this clinical study will be used to create a harmonized, high-quality database for the development of exploratory interpretable artificial intelligence models for predicting DR progression and stage as well as predict the values of cardiovascular risk factors, and the risk of developing cardiovascular complications.
- Conditions
- Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diabetic Retinopathy Staging
Change in score on the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (ETDRS DRSS; range 10-85; higher scores indicate worse severity), measured on Optos Ultra-Widefield Fundus Photography.
Measured: Baseline to 12 months
Diabetic Retinopathy (DR) Progression, measured on the OPTOS Ultra-widefield Fundus Photography (UWF-FP)
Defined as a ≥2-step worsening on the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (ETDRS DRSS)
Measured: Baseline to 12 months
Proportion of participants with ≥15-letter loss in ETDRS Best-Corrected Visual Acuity (BCVA)
≥15-letter loss on the ETDRS BCVA chart (measured with Snellen or LogMAR charts converted to the ETDRS scale).
Measured: Baseline to 12 months
Incidence of Major Adverse Cardiovascular Events (MACE)
Incidence of myocardial infarction, ischemic stroke, or hospitalization for heart failure, extracted from medical history and confirmed by investigator.
Measured: Baseline to 12 months
Secondary outcomes (16)
Number of microaneurysms in the central ETDRS area (90°)
Count of microaneurysms within the central ETDRS grading area (90 degrees), assessed by human graders on Optos Ultra-Widefield Fundus Photography images.
Measured: Baseline to 12 months
Number of microaneurysms in the peripheral retina (90-200°)
Count of microaneurysms in the peripheral retinal area (between 90 and 200 degrees), assessed by human graders on Optos Ultra-Widefield Fundus Photography images.
Measured: Baseline to 12 months
Presence of hemorrhages in the central ETDRS area
Presence of retinal hemorrhages within the central ETDRS grading area (90 degrees), identified by human graders on Optos Ultra-Widefield Fundus Photography. Reported as the percentage of affected eyes.
Measured: Baseline to 12 months
Presence of peripheral retinal hemorrhages (90-200°)
Presence of retinal hemorrhages in the peripheral retina (90-200 degrees), assessed through human grading of Optos Ultra-Widefield Fundus Photography images. Reported as the percentage of affected eyes.
Measured: Baseline to 12 months
Presence of exudates in the retina
Presence of hard exudates identified by human graders on Optos Ultra-Widefield Fundus Photography. Reported as the percentage of eyes displaying ≥1 exudate.
Measured: Baseline to 12 months
Presence of cotton wool spots in the retina
Presence of cotton wool spots identified by human graders on Optos Ultra-Widefield Fundus Photography. Reported as the percentage of affected eyes.
Measured: Baseline to 12 months
Correlation between retinal microaneurysm count and glycated hemoglobin (HbA1c)
Correlation between the number of microaneurysms identified on Optos Ultra-Widefield Fundus Photography and (HbA1c) levels obtained through clinical laboratory testing. Reported as a correlation coefficient (r).
Measured: Baseline to 12 months
Retinal vessel density
Quantitative vessel density measured using Optical Coherence Tomography Angiography. Expressed in inverse millimeters (mm-1)
Measured: Baseline to 12 months
Correlation between retinal vessel density and systolic blood pressure
Correlation between vessel density quantified using Optical Coherence Tomography Angiography and systolic blood pressure collected during clinical evaluation. Reported as a correlation coefficient (r).
Measured: Baseline to 12 months
Abnormal intercapillary spaces (AIS) in the retina
Count of abnormal intercapillary spaces assessed using Optical Coherence Tomography Angiography automated analysis tools. Expressed as the percentage of pixels associated with the presence of abnormal intercapillary spaces relative to the total number of pixels in the slab.
Measured: Baseline to 12 months
Correlation between abnormal intercapillary spaces (AIS) and major adverse cardiovascular events (MACE)
Correlation between the number of abnormal intercapillary spaces measured on Optical Coherence Tomography Angiography and the occurrence of (MACE). Reported as a correlation coefficient (r).
Measured: Baseline to 12 months
Retinal venous calibre
Mean venous calibre measured in micrometers (μm) through automated analysis of Color Fundus Photography images.
Measured: Baseline to 12 months
Retinal vascular tortuosity
Vascular tortuosity calculated from Color Fundus Photography images using validated image analysis algorithms.
Measured: Baseline to 12 months
Microaneurysm turnover (MAT) over one year
Number of microaneurysms appearing and disappearing over a one-year period, quantified through automated analysis of sequential Color Fundus Photography images.
Measured: Baseline to 12 months
Retinal fractal dimension
Fractal dimension of the retinal vascular network, calculated using an automated feature extraction applied to Color Fundus Photography images.
Measured: Baseline to 12 months
Foveal Avascular Zone (FAZ) metrics
Area of the foveal avascular zone measured in square millimeters (mm²) using Optical Coherence Tomography Angiography automated segmentation tools.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start3 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Association for Innovation and Biomedical Research on Light and Image
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Sponsor
- Investigators
- Luís Mendes, PhD, Study director, Association for Innovation and Biomedical Research on Light and Image
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417410
- Sponsor's protocol ID
- 4C-2025-16
- Acronym
- ALERT
- Status last verified
- Feb 2026
- First submitted
- 19 Nov 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cunha-Vaz J, Mendes L. Characterization of Risk Profiles for Diabetic Retinopathy Progression. J Pers Med. 2021 Aug 23;11(8):826. doi: 10.3390/jpm11080826.
PubMed 34442470Marques IP, Madeira MH, Messias AL, Santos T, Martinho AC, Figueira J, Cunha-Vaz J. Retinopathy Phenotypes in Type 2 Diabetes with Different Risks for Macular Edema and Proliferative Retinopathy. J Clin Med. 2020 May 12;9(5):1433. doi: 10.3390/jcm9051433.
PubMed 32408522Santos AR, Almeida AC, Rocha AC, Reste-Ferreira D, Marques IP, Cunha-Vaz Martinho A, Mendes L, Santos T, Lewis W, Cunha-Vaz J. CENTRAL AND PERIPHERAL INVOLVEMENT OF THE RETINA IN THE INITIAL STAGES OF DIABETIC RETINOPATHY. Retina. 2024 Apr 1;44(4):700-706. doi: 10.1097/IAE.0000000000004021.
PubMed 38109709Sato Y, Lee Z, Hayashi Y. Subclassification of preproliferative diabetic retinopathy and glycemic control: relationship between mean hemoglobin A1C value and development of proliferative diabetic retinopathy. Jpn J Ophthalmol. 2001 Sep-Oct;45(5):523-7. doi: 10.1016/s0021-5155(01)00380-x.
PubMed 11583677Silva PS, Cavallerano JD, Haddad NM, Kwak H, Dyer KH, Omar AF, Shikari H, Aiello LM, Sun JK, Aiello LP. Peripheral Lesions Identified on Ultrawide Field Imaging Predict Increased Risk of Diabetic Retinopathy Progression over 4 Years. Ophthalmology. 2015 May;122(5):949-56. doi: 10.1016/j.ophtha.2015.01.008. Epub 2015 Feb 19.
PubMed 25704318IDF Diabetes Atlas 9th edition. (2019). IDF Diabetes Atlas 9th edition 2019. In International Diabetes Federation Diabetes Atlas, Ninth Edition.
Marques, I., Mendes, L., & Cunha-Vaz, J. (2018). Noninvasive Multimodal Imaging of Diabetic Retinopathy (pp. 88-101). https://doi.org/10.1159/000487414
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of DR Progression to Identify Risks and Need for Treatment
- ClinicalTrials.gov ID
- NCT07417410
- Acronym / sponsor ID
- ALERT / 4C-2025-16
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Feb 2026 (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 goal of this observational study is to understand whether vascular and structural changes in the eyes caused by diabetes can help predict which people are more likely to experience worsening diabetic retinopathy (a diabetes-related eye disease) and how these eye changes are related to cardiovascular complications.
The study will include about 1,000 people with type 2 diabetes, aged 35 to 90 years, and will take place over twelve months. It may also include a retrospective component, where existing medical and imaging data collected from previous visits (within the last 1 to 5 years) will be analyzed.
The main questions it aims to answer are:
- Can eye vessel and tissue changes, observed through modern imaging techniques and clinical data, help better describe and predict which cases of diabetic retinopathy will become more severe?
- Can these same eye changes help predict the presence and risk of cardiovascular problems-such as heart disease or stroke-in people living with type 2 diabetes?
Detailed description
Diabetic Retinopathy (DR) is a leading cause of vision loss in adults with type 2 diabetes (T2D) and is associated with systemic complications, including cardiovascular disease. Early identification of patients at high risk of DR progression and cardiovascular events is critical to optimizing clinical management. Retinal imaging biomarkers, combined with clinical and demographic data, provide an opportunity to better understand disease mechanisms, predict progression of DR and associated cardiovascular complications, and guide personalized interventions.
The aim of this study is to investigate the influence of central versus peripheral retinal lesions on DR progression and staging, characterize associations between retinal biomarkers and cardiovascular risk factors and major adverse cardiovascular events (MACE), and contribute to the understanding of pathophysiological mechanisms underlying DR in T2D patients. The study will also generate a high-quality, harmonized database to support the development of artificial intelligence (AI) models.
This study aims to determine the extent to which central and peripheral retinal lesions, together with quantitative imaging biomarkers, contribute to the progression and staging of DR and the occurrence of cardiovascular complications in patients with T2D. Additionally, in the scope of the ALERT project (supported by Fundação para Ciência e Tecnologia (FCT); COMPETE2030-FEDER-00921900), the data of this clinical study will be used to create a harmonized, high-quality database for the development of exploratory interpretable artificial intelligence models for predicting DR progression and stage as well as predict the values of cardiovascular risk factors, and the risk of developing cardiovascular complications.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1.000 participants with T2D will be included in this study, in a recruitment period of 12 months.
Key inclusion criteria (4 listed)
- Diagnosed with type 2 diabetes according to the 1985 WHO criteria.
- Age between 35 and 90 years.
- Retrospective visit or referenced patients. For the retrospective visit, a documented follow-up of 1-5 years is required, with at least one clinical visit. For the referenced patients, it is required that they have either diabetic retinopathy at the baseline visit, the presence of at least one cardiovascular risk factor at the baseline visit, or cardiovascular complications at the baseline visit.
- Signed informed consent.
Key exclusion criteria (6 listed)
- Previous laser photocoagulation or intravitreal injections (consider if corticosteroids were administered).
- Presence of clinically significant macular edema (CSME) with vision loss or requiring immediate treatment.
- Proliferative diabetic retinopathy.
- Any ocular surgery within the previous 3 months.
- Renal Replacement Therapy (Hemodialysis, Peritoneal Dialysis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Diabetic Retinopathy Staging
Time frame: Baseline to 12 months
Change in score on the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (ETDRS DRSS; range 10-85; higher scores indicate worse severity), measured on Optos Ultra-Widefield Fundus Photography.
Diabetic Retinopathy (DR) Progression, measured on the OPTOS Ultra-widefield Fundus Photography (UWF-FP)
Time frame: Baseline to 12 months
Defined as a ≥2-step worsening on the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (ETDRS DRSS)
Proportion of participants with ≥15-letter loss in ETDRS Best-Corrected Visual Acuity (BCVA)
Time frame: Baseline to 12 months
≥15-letter loss on the ETDRS BCVA chart (measured with Snellen or LogMAR charts converted to the ETDRS scale).
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: Baseline to 12 months
Incidence of myocardial infarction, ischemic stroke, or hospitalization for heart failure, extracted from medical history and confirmed by investigator.
16 secondary outcomes
Number of microaneurysms in the central ETDRS area (90°)
Time frame: Baseline to 12 months
Number of microaneurysms in the peripheral retina (90-200°)
Time frame: Baseline to 12 months
Presence of hemorrhages in the central ETDRS area
Time frame: Baseline to 12 months
Presence of peripheral retinal hemorrhages (90-200°)
Time frame: Baseline to 12 months
Presence of exudates in the retina
Time frame: Baseline to 12 months
Presence of cotton wool spots in the retina
Time frame: Baseline to 12 months
Correlation between retinal microaneurysm count and glycated hemoglobin (HbA1c)
Time frame: Baseline to 12 months
Retinal vessel density
Time frame: Baseline to 12 months
Correlation between retinal vessel density and systolic blood pressure
Time frame: Baseline to 12 months
Abnormal intercapillary spaces (AIS) in the retina
Time frame: Baseline to 12 months
Correlation between abnormal intercapillary spaces (AIS) and major adverse cardiovascular events (MACE)
Time frame: Baseline to 12 months
Retinal venous calibre
Time frame: Baseline to 12 months
Retinal vascular tortuosity
Time frame: Baseline to 12 months
Microaneurysm turnover (MAT) over one year
Time frame: Baseline to 12 months
Retinal fractal dimension
Time frame: Baseline to 12 months
Foveal Avascular Zone (FAZ) metrics
Time frame: Baseline to 12 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 2 Mar 2026.
- Background: PubMed 34442470Cunha-Vaz J, Mendes L. Characterization of Risk Profiles for Diabetic Retinopathy Progression. J Pers Med. 2021 Aug 23;11(8):826. doi: 10.3390/jpm11080826.
- Background: PubMed 32408522Marques IP, Madeira MH, Messias AL, Santos T, Martinho AC, Figueira J, Cunha-Vaz J. Retinopathy Phenotypes in Type 2 Diabetes with Different Risks for Macular Edema and Proliferative Retinopathy. J Clin Med. 2020 May 12;9(5):1433. doi: 10.3390/jcm9051433.
- Background: PubMed 38109709Santos AR, Almeida AC, Rocha AC, Reste-Ferreira D, Marques IP, Cunha-Vaz Martinho A, Mendes L, Santos T, Lewis W, Cunha-Vaz J. CENTRAL AND PERIPHERAL INVOLVEMENT OF THE RETINA IN THE INITIAL STAGES OF DIABETIC RETINOPATHY. Retina. 2024 Apr 1;44(4):700-706. doi: 10.1097/IAE.0000000000004021.
- Background: PubMed 11583677Sato Y, Lee Z, Hayashi Y. Subclassification of preproliferative diabetic retinopathy and glycemic control: relationship between mean hemoglobin A1C value and development of proliferative diabetic retinopathy. Jpn J Ophthalmol. 2001 Sep-Oct;45(5):523-7. doi: 10.1016/s0021-5155(01)00380-x.
- Background: PubMed 25704318Silva PS, Cavallerano JD, Haddad NM, Kwak H, Dyer KH, Omar AF, Shikari H, Aiello LM, Sun JK, Aiello LP. Peripheral Lesions Identified on Ultrawide Field Imaging Predict Increased Risk of Diabetic Retinopathy Progression over 4 Years. Ophthalmology. 2015 May;122(5):949-56. doi: 10.1016/j.ophtha.2015.01.008. Epub 2015 Feb 19.
- BackgroundIDF Diabetes Atlas 9th edition. (2019). IDF Diabetes Atlas 9th edition 2019. In International Diabetes Federation Diabetes Atlas, Ninth Edition.
- BackgroundMarques, I., Mendes, L., & Cunha-Vaz, J. (2018). Noninvasive Multimodal Imaging of Diabetic Retinopathy (pp. 88-101). https://doi.org/10.1159/000487414
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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.
Luís Mendes, PhD study director
Association for Innovation and Biomedical Research on Light and Image
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
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 4 inclusion and 6 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 2 Mar 2026. 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 Portugal. 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 Joana F Tavares, PhD (239480137, alert_4c@aibili.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diabetic Retinopathy Staging (time frame: Baseline to 12 months). The study lists 4 primary outcomes in all. 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 NCT07417410, which also lists 7 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 2 Mar 2026.