Following eye changes in people with type 2 diabetes and diabetic retinopathy
Follows eye changes over 2 years in people with type 2 diabetes and retinopathy.
Plain-language title generated from the registry record
Registry title: Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients
Key facts
- Where
- Coimbra, PortugalSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 35 and 80 years old?
Source: NCT07458516, who can take part
Where in Portugal
- AIBILI-CEC (AIBILI-Clinical Trial Centre)Coimbra, PortugalTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Association for Innovation and Biomedical Research on Light and Image
- Trial code
- NCT07458516
- Record updated
- 23 October 2026
- Original description
The purpose of this clinical study is to explore structural and functional imaging and systemic biomarkers of diabetic retinopathy (DR) progression, in eyes from Type 2 Diabetes (T2D) patients with moderate to severe non-proliferative diabetic retinopathy (NPDR) and mild proliferative diabetic retinopathy (PDR) using state of the art methodologies, commonly applied in clinical practice, over a period of two years. This study will provide longitudinal data to better understand retinal changes in moderate to severe diabetic retinopathy and early proliferative diabetic retinopathy and help guide timely interventions to prevent vision loss. One or two eligible eyes per participant may be included in the study. The study will evaluate retinal vascular closure, ischemia, leakage, neurodegeneration, macular edema and microaneurysm dynamics and their association with disease progression.Read full original descriptionShow less
IMaging Pre-PrOlifeRative sTAge of Diabetic retiNopaThy to Guarantee Timely Treatment - IMPORTANT
The purpose of this clinical study is to explore structural and functional imaging and systemic biomarkers of diabetic retinopathy (DR) progression, in eyes from Type 2 Diabetes (T2D) patients with moderate to severe non-proliferative diabetic retinopathy (NPDR) and mild proliferative diabetic retinopathy (PDR) using state of the art methodologies, commonly applied in clinical practice, over a period of two years. This study will provide longitudinal data to better understand retinal changes in moderate to severe diabetic retinopathy and early proliferative diabetic retinopathy and help guide timely interventions to prevent vision loss. One or two eligible eyes per participant may be included in the study. The study will evaluate retinal vascular closure, ischemia, leakage, neurodegeneration, macular edema and microaneurysm dynamics and their association with disease progression.
Inclusion: 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: Uncontrolled glaucoma (intraocular pressure > 25 mmHg regardless of concomitant IOP-lowering medications) or neovascular glaucoma; Previous panretinal photocoagulation (PRP) or intravitreal injection treatment; Any eye surgery within 6 months prior to the inclusion visit; Any sign of iris neovascularization, vitreous, or pre-retinal hemorrhage; Significant media opacities including severe cataract, corneal scarring or edema, or vitreous hemorrhage that precludes fundus evaluation; Other retinal vascular diseases (ocular ischemic syndrome, retinal arterial or venous occlusion, exudative age-related macular degeneration, etc.); 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; Pupil dilation < 5 mm.