New study aims to catch diabetic eye disease before it steals sight
NCT ID NCT07458516
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study follows 100 people with type 2 diabetes who have moderate to severe diabetic retinopathy, a condition that can lead to vision loss. Researchers will use advanced eye scans and imaging to track changes in the retina over two years. The goal is to find better ways to predict when treatment is needed to prevent blindness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help doctors identify the right time to treat diabetic retinopathy, potentially preventing vision loss in people with type 2 diabetes.
- What could go wrong
- This is an observational study, not a treatment trial. It will not directly test any new drug or therapy, and the findings may not lead to immediate changes in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Study Population: Patients with moderate to severe NPDR and mild PDR. Ideally, the distribution of participants will be as follows: 40 for Diabetic Retinopathy Severity Scale (DRSS) level 43, 40 for DRSS level 47, and 20 for DRSS levels 53-61
- Ages
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35 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AIBILI-CEC (AIBILI-Clinical Trial Centre)
RECRUITINGCoimbra, 3000-548, Portugal
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