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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.

Key facts

Who runs it
Association for Innovation and Biomedical Research on Light and Image
Where
Coimbra, PortugalSee the site
Trial code
Registry title
Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients
Status
Recruiting
People taking part
100 people, planned
Started
24 Nov 2025
Expected to end
Nov 2028
Type of study
Observational
Record updated
23 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes who have moderate to severe non-proliferative or mild proliferative diabetic retinopathy and do not need eye treatment right away.

Age
35 to 80 years
Sex
All sexes can join.
Disease stage
Non-proliferative diabetic retinopathy (DRSS levels 43, 47, 53) or mild proliferative diabetic retinopathy (DRSS level 61), where laser (PRP) or anti-VEGF injections can safely wait at least 6 months.
Earlier treatment
No earlier panretinal photocoagulation (PRP) or injection into the eye. No eye surgery in the 6 months before the first visit.

Main reasons for not taking part

  • Central subfield thickness (CST) above 400 μm
  • Any sign of retinal fibrovascular proliferation
  • Uncontrolled glaucoma or neovascular glaucoma
  • Bleeding in the vitreous or in front of the retina, or new vessels on the iris
  • Cloudy eye media, such as severe cataract, that blocks the view of the back of the eye

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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

Check if you might fit

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?

Where in Portugal

  • AIBILI-CEC (AIBILI-Clinical Trial Centre)Coimbra, PortugalContact: Inês P Marques, MD PhDTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
IMaging Pre-PrOlifeRative sTAge of Diabetic retiNopaThy to Guarantee Timely Treatment - IMPORTANT
Plain-language title
Following eye changes in people with type 2 diabetes and diabetic retinopathyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07458516, who can take part
Record updated
23 October 2026