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AzTrials

Diabetic RetinopathyPREDICTIONNCT05581225

Prediction of Progression of Retinal Ischemia in Diabetes

An observational study of Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Diabetes Mellitus (DM) is a major public health problem with significant socioeconomic implications due to its increased prevalence. Diabetic retinopathy (DR) is the most frequent complication in DM patients and remains the leading cause of legal blindness in working-age populations (Yau et al., 2012). Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Diabetic Retinopathy
How many people
62 participants
Where
1 sitePortugal
Study dates
2 Dec 2022to 31 Oct 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • Adult, Older adult

Study population: 52 eyes from 52 individuals with T2D and NPDR with ETDRS DRSS grade 43, 47 or 53, with or without previous treatment, will be included in this study, in a recruitment period of 14 months.

Who may be able to join

  • DM type 2 according to 1985 WHO criteria.
  • Age between 35 and 80 years.
  • BCVA ≥ 75 letters (20 /32).
  • Refraction with a spherical equivalent less than 5 Diopters.
  • NPDR levels 43, 47 or 53 (based on the ETDRS criteria - 7 fields CFP).

Who cannot join

  • Cataract or other eye disease that may interfere with fundus examinations.
  • HBA1C ≥ 12%
  • Any eye surgery within a period of 6-months before the inclusion visit date.
  • Other retinal vascular disease.
  • Previous laser or intravitreal injection treatment.
  • Dilatation of the pupil < 5 mm.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • AIBILI-CEC (AIBILI- Clinical Trials Centre)

    Coimbra, 3000-548

Other trials in Portugal

About this study

Diabetes Mellitus (DM) is a major public health problem with significant socioeconomic implications due to its increased prevalence. Diabetic retinopathy (DR) is the most frequent complication in DM patients and remains the leading cause of legal blindness in working-age populations (Yau et al., 2012). Differentiating patients with higher vs low risk of progression to vision-threatening complications is of paramount importance for an efficient managing of the disease to prevent vision disability.

PREDICTION is a longitudinal prospective clinical study in DMT2 patients with a higher risk of progression to explore possible imaging, functional and systemic biomarkers of progression, using non-invasive methods, commonly applied in the clinical practice. Investigating the retinal vascular network (vessel density metrics with Optical Coherence Tomography Angiography) will allow a better understanding of the evolution of capillary closure and ischemia, two main risk factors for DR worsening.

Read the detailed description

Patients with Mild to Severe NPDR (ETDRS DRSS 43-53) often progress to PDR and/or CI-DME (ETDRS Report). However, it is unclear which patients in this group are likely to progress. Previous studies have shown that diabetic macular ischemia (DMI) is a risk factor for progression of DR. This study aims to correlate baseline OCTA metrics with visual function and identify risk factors for progression from NPDR to PDR and/or CI-DME.

Medical subject headings
Diabetic Retinopathy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. One and 2-steps change on ETDRS severity level (using standard 7-fields CFP acquisitions at 30º and in Wide-field 100º acquisitions).

    Identify and characterize the progression of retinal microvascular changes (vascular occlusion) occurring in eyes with moderate to severe NPDR (ETDRS severity levels 43, 47 or 53).

    Measured: 48 months

  2. Changes in Vessel density (VD) metrics (skeletonized VD, binarized VD (PD), considering macular region and midperiphery.

    Explore new OCTA vascular metrics and identify which can be used as imaging biomarkers to better identify DR progression (skeletonized VD, binarized VD (PD).

    Measured: 48 months

  3. Changes in geometric perfusion deficits (GPD) on the superficial and deep retinal vascular layers on SS-OCTA, considering macular region and midperiphery.

    Explore new OCTA vascular metrics and identify which can be used as imaging biomarkers to better identify DR progression geometric perfusion deficits (GPD) using 3mm x 3mm and wide-field 15mm x 15mm OCTA acquisitions.

    Measured: 48 months

Secondary outcomes (7)

  1. Changes in FAZ area on OCTA

    Measured: 48 months

  2. Changes in perimeter on OCTA.

    Measured: 48 months

  3. Changes in circularity on OCTA.

    Measured: 48 months

  4. Changes in GCL + IPL thickness evaluated by SD-OCT.

    Measured: 48 months

  5. Changes in CRT and layer by layer thickness evaluated by SD-OCT.

    Measured: 48 months

  6. Changes in BCVA (ETDRS letters chart).

    Measured: 48 months

  7. Changes in mean luminous sensitivity in dB, evaluated by Microperimetry.

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start2 Dec 2022
  3. Primary completion2 Feb 2024
  4. Study completion31 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05581225
Sponsor's protocol ID
4C-029-22
Acronym
PREDICTION
Status last verified
May 2025
First submitted
12 Oct 2022
Last updated
9 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

One and 2-steps change on ETDRS severity level (using standard 7-fields CFP acquisitions at 30º and in Wide-field 100º acquisitions). (time frame: 48 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05581225.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

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