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NCT Number: NCT05581225

Prediction of Progression of Retinal Ischemia in Diabetes

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AIBILI-CEC (AIBILI- Clinical Trials Centre)

Coimbra, 3000-548, Portugal

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

    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).

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

    Time frame: 48 months

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

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

    Time frame: 48 months

    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.

Secondary outcomes

  1. Changes in FAZ area on OCTA

    Time frame: 48 months

  2. Changes in perimeter on OCTA.

    Time frame: 48 months

  3. Changes in circularity on OCTA.

    Time frame: 48 months

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

    Time frame: 48 months

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

    Time frame: 48 months

  6. Changes in BCVA (ETDRS letters chart).

    Time frame: 48 months

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

    Time frame: 48 months

Sponsors and collaborators

Lead sponsor

Association for Innovation and Biomedical Research on Light and Image

Other

Registry information

Acronym: PREDICTION

Important dates

Study start
2022
Primary completion
2024
Study completion
2028
First posted
Oct 14, 2022
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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