Analysis of DR Progression to Identify Risks and Need for Treatment

NCT07417410 | Recruiting

• 1 other identifier: 4C-2025-16
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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?

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  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).

  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.

  Baseline to 12 months

Secondary Outcomes (16)

• Number of microaneurysms in the central ETDRS area (90°)

  Baseline to 12 months

• Number of microaneurysms in the peripheral retina (90-200°)

  Baseline to 12 months

• Presence of hemorrhages in the central ETDRS area

  Baseline to 12 months

• Presence of peripheral retinal hemorrhages (90-200°)

  Baseline to 12 months

• Presence of exudates in the retina

  Baseline to 12 months

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1.000 participants with T2D will be included in this study, in a recruitment period of 12 months.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Association for Innovation and Biomedical Research on Light and Image: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

AIBILI-Clinical Trial Centre

Portugal, Coimbra District, 3000-548, Portugal

RECRUITING

Related Publications (7)

• 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.

  PMID: 34442470 BACKGROUND

• Marques 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.

  PMID: 32408522 BACKGROUND

• Santos 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.

  PMID: 38109709 BACKGROUND

• Sato 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.

  PMID: 11583677 BACKGROUND

• Silva 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.

  PMID: 25704318 BACKGROUND

• IDF Diabetes Atlas 9th edition. (2019). IDF Diabetes Atlas 9th edition 2019. In International Diabetes Federation Diabetes Atlas, Ninth Edition.

  BACKGROUND

• Marques, I., Mendes, L., & Cunha-Vaz, J. (2018). Noninvasive Multimodal Imaging of Diabetic Retinopathy (pp. 88-101). https://doi.org/10.1159/000487414

  BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Luís Mendes, PhD

  Association for Innovation and Biomedical Research on Light and Image

  STUDY DIRECTOR

Central Study Contacts

Joana F Tavares, PhD

CONTACT

239480137; alert_4c@aibili.pt

Liliana C Soares, MsC

CONTACT

239480115; alert_4c@aibili.pt

Study Design

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

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: February 18, 2026
• Study Start: November 3, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

PT (1)