Tracking retinal changes over two years in people with moderate to early proliferative diabetic retinopathy
IMaging Pre-PrOlifeRative sTAge of Diabetic retiNopaThy to Guarantee Timely Treatment - IMPORTANT
This project will try to find imaging, functional, and blood markers that show whether retinopathy is getting worse over two years in people with type 2 diabetes and moderate-to-mildly advanced disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 35 Years to 80 Years |
| Sex | All |
| Sponsor | Association for Innovation and Biomedical Research on Light and Image Academic / other |
| Locations | 1 site (Coimbra) |
| Trial ID | NCT07458516 on ClinicalTrials.gov |
What this trial studies
This is a two-year longitudinal observational project enrolling adults with type 2 diabetes who have moderate to severe non-proliferative diabetic retinopathy or mild proliferative disease. Participants will undergo serial retinal imaging (including ultra-widefield fundus imaging and OCT), visual function testing, and systemic biomarker sampling at scheduled visits using widely used clinical methods. The study will map changes in retinal structure, perfusion, and molecular markers to identify patterns that precede progression to proliferative disease or diabetic macular edema. Longitudinal data aim to support better timing of interventions to prevent vision loss.
Who should consider this trial
Good fit: Adults aged 35–80 with type 2 diabetes, best-corrected visual acuity ≥69 letters (≈20/40), spherical equivalent <5 diopters, and moderate-to-severe NPDR (DRSS 43, 47, 53) or mild PDR (DRSS 61) who can safely defer PRP/anti-VEGF for at least six months and provide informed consent.
Not a fit: Patients with advanced proliferative disease needing immediate panretinal photocoagulation or intravitreal anti-VEGF, central subfield thickness >400 μm, significant macular edema, or other ocular conditions that impair reliable imaging are unlikely to benefit from this observational protocol.
Why it matters
Potential benefit: If successful, the results could help doctors identify patients at higher risk of vision-threatening progression earlier so treatments can be timed to prevent vision loss.
How similar studies have performed: Previous observational work using OCT and VEGF-related biomarkers has shown links to progression, but combining ultra-widefield imaging, functional tests, and systemic biomarkers in a longitudinal framework is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 2 diabetes mellitus (T2D) according to 1985 World Health Organization (WHO) criteria. * Age between 35 and 80 years. * Best-corrected visual acuity (BCVA) ≥ 69 letters (20/40). * Refraction with a spherical equivalent less than 5 diopters. * Non-proliferative diabetic retinopathy (NPDR; DRSS levels 43, 47, 53) or mild proliferative diabetic retinopathy (PDR; DRSS level 61: Neovascularization Elsewhere (NVE) \< ½ disc area in ≥ 1 quadrant, no Neovascularization of the Disc (NVD), no vitreous or sub-hyaloid hemorrhage), in which panretinal photocoagulation (PRP) and/or intravitreal anti-VEGF treatment can safely be deferred for at least 6 months, based on consensus between patient and investigator - using ETDRS criteria, 7-field equivalent area on ultra-widefield fundus imaging. * Ability to understand and sign the written Informed Consent Form (ICF). Exclusion Criteria: * Central subfield thickness (CST) \> 400 μm (fluid allowed if CST ≤ 400 μm and foveal contour is normal, as determined by the Central Reading Centre, and treatment is not immediately required). * Any sign of retinal fibrovascular proliferation. * Uncontrolled glaucoma (intraocular pressure \> 25 mmHg regardless of concomitant IOP-lowering medications) or neovascular glaucoma. * Any sign of iris neovascularization, vitreous, or pre-retinal hemorrhage. * Other retinal vascular diseases (ocular ischemic syndrome, retinal arterial or venous occlusion, exudative age-related macular degeneration, etc.). * Previous panretinal photocoagulation (PRP) or intravitreal injection treatment. * Any eye surgery within 6 months prior to the inclusion visit. * Significant media opacities including severe cataract, corneal scarring or edema, or vitreous hemorrhage that precludes fundus evaluation. * Pupil dilation \< 5 mm.
Where this trial is running
Coimbra
- AIBILI-CEC (AIBILI-Clinical Trial Centre) — Coimbra, Portugal (Recruiting)
Study contacts
- Principal investigator: Inês P Marques, MD PhD — AIBILI - Associação para a Investigação Biomédica e Inovação em Luz e Imagem
- Study coordinator: Joana Tavares, PhD
- Email: jftavares@aibli.pt
- Phone: +351239480137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.