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Eye scans could predict vision loss in diabetes patients

NCT ID NCT04636307

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 202 adults with type 2 diabetes and early-stage diabetic eye disease (non-proliferative diabetic retinopathy). Researchers used non-invasive eye scans to find markers that could predict if the disease would get worse or lead to sight-threatening problems. The goal was to better understand how the retina changes over time, without any treatment being tested.

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

202 people

The number who actually took part.

Started

Sep 2021

Finished

May 2025

Lead sponsor

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

Diabetes Type-2 and NPDR (levels 35, 43, 47 or 53)

Ages

35 to 90 years

Sex

Anyone

Show 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 * Diabetes type 2 according to 1985 WHO criteria; * Age between 35 and 90 years; * NPDR levels 35, 43, 47 or 53 (based on the ETDRS criteria - 7 fields CFP) after confirmation by the Reading Centre; * Refraction with a spherical equivalent less than 5 Dp; * Informed consent. EXCLUSION CRITERIA * Repeated HbA1C \> 10% in the first visit; * Cataract or other eye disease that may interfere with fundus examinations; * Age-related macular degeneration, glaucoma, vitreomacular disease, or other retinal vascular disease, or any ocular condition that, in the opinion of the investigator may affect retinopathy status or alter visual acuity during the study; * Any eye surgery within a period of 6-months; * Previous laser treatment or previous intravitreal injections; * Any patient comorbidity likely to affect the eye and not related with diabetes or cardiovascular disease; * Presence of CIME (CRT ≥ 290 μm in women and ≥ 305 μm in men) with vision loss or needing immediate treatment, according to clinical practice; * Dilatation of the pupil \< 5 mm; * Uncontrolled systemic hypertension (values outside normal range: systolic 70-210 mmHg and diastolic 50-120 mmHg).

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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.

Contacts and locations

Locations

  • CS001 Centre for Clinical Trials - AIBILI

    Coimbra, Portugal

  • CS020 - G. B. Bietti Eye Foundation - IRCCS

    Roma, Italy

  • CS042 - Department of Ophthalmology, University Hospital, CHU Dijon

    Dijon, France

  • CS063 - Excellence Eye Research Centre, University G. d'Annunzio of Chieti-Pescara

    Pescara, Italy

  • CS067- Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffael, Milan

    Milan, Italy

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