Prediction of Progression of Retinal Ischemia in Diabetes

NCT05581225 | Active Not Recruiting DMC

• 1 other identifier: 4C-029-22
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (3)

• 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).

  48 months

• 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).

  48 months

• 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.

  48 months

Secondary Outcomes (7)

• Changes in FAZ area on OCTA

  48 months

• Changes in perimeter on OCTA.

  48 months

• Changes in circularity on OCTA.

  48 months

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

  48 months

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

  48 months

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• Cataract or other eye disease that may interfere with fundus examinations.
• HBA1C ≥ 12%
• Other retinal vascular disease.
• Previous laser or intravitreal injection treatment.
• Dilatation of the pupil \< 5 mm.

Sponsors & Collaborators

• Association for Innovation and Biomedical Research on Light and Image: lead

Study Sites (1)

AIBILI-CEC (AIBILI- Clinical Trials Centre)

Coimbra, 3000-548, Portugal

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: December 2, 2022
• Primary Completion: February 2, 2024
• Study Completion (Estimated): October 31, 2028
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)