NCT07458516Recruiting
Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients
IMaging Pre-PrOlifeRative sTAge of Diabetic retiNopaThy to Guarantee Timely Treatment - IMPORTANT
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 26 Feb 2026
- Start date
- 24 Nov 2025
- Primary completion date
- Nov 2027
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Diseases
- Type 2 diabetes, Diabetic eye disease
- NCT number
- NCT07458516
What you commit to
- Study type: Observational
- Planned participants: 100
- From 24 Nov 2025 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Age
- Other retinal vascular diseases (ocular ischemic syndrome, retinal arterial or venous occlusion, exudative age-related macular degeneration, etc.).
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 35 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AIBILI-CEC (AIBILI-Clinical Trial Centre) Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.