Diabetic RetinopathyDiabetes Mellitus, Type 2Diabetic ComplicationRetinal Disease
Study summary
The purpose of this clinical study is to explore imaging, functional and systemic biomarkers of diabetic retinopathy (DR) progression, in Type 2 Diabetes (T2D) patients with moderate to severe non-proliferative diabetic retinopathy (NPDR) and mild proliferative diabetic retinopathy (PDR) using state of the art methodologies, commonly applied in clinical practice, over a period of two years. This study will provide longitudinal data to better understand retinal changes in moderate to severe diabetic retinopathy and early proliferative diabetic retinopathy and help guide timely interventions to prevent vision loss.
Eligibility
Sex
ALL
Min age
35 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Changes in capillary skeletonized vessel density (SVD) — Baseline to 24 months Evaluate baseline differences and longitudinal changes (from baseline to month 24) in capillary non-perfusion using skeletonized vessel density (SVD) in the superficial and deep retinal vascular layers assessed with Optical Coherence Tomography Angiography.
Changes in capillary perfusion density (PD) using OCTA — Baseline to 24 months Evaluate baseline differences and longitudinal changes (from baseline to month 24) in capillary non-perfusion using binarized vessel density (VD) as perfusion density (PD) in the superficial and deep retinal vascular layers assessed with Optical Coherence Tomography Angiography.
Foveal Avascular Zone (FAZ) area — Baseline to 24 months Evaluate baseline differences and longitudinal changes (from baseline to month 24) in the area of the foveal avascular zone measured in square millimeters (mm²) using Optical Coherence Tomography Angiography automated segmentation tools across DRSS levels.
Foveal Avascular Zone (FAZ) perimeter — Baseline to 24 months Evaluate baseline differences and longitudinal changes (from baseline to month 24) in the perimeter of the foveal avascular zone measured in millimeters (mm) using Optical Coherence Tomography Angiography automated segmentation tools across DRSS levels.
Foveal Avascular Zone (FAZ) circularity — Baseline to 24 months Evaluate baseline differences and longitudinal changes (from baseline to month 24) in the circularity of the foveal avascular zone using Optical Coherence Tomography Angiography automated segmentation tools across DRSS levels.
Changes in retinal ischemic area using UWF FFA — Baseline to 24 months Evaluate baseline differences and longitudinal changes (from baseline to month 24) in retinal ischemic area (mm2) across DRSS levels.
Changes in central retinal thickness (CRT) — Baseline to 24 months Evaluate baseline differences and longitudinal changes (from baseline to month 24) in Central Retinal Thickness (CRT) assessed using Optical Coherence Tomography (OCT) across DRSS levels.
Changes in central intraretinal fluid — Baseline to 24 months Evaluate baseline differences and longitudinal changes (from baseline to month 24) in intraretinal fluid (layer-specific) assessed using Optical Coherence Tomography (OCT) across DRSS levels.
Changes in Disorganisation of Retinal Inner Layers (DRIL) — Baseline to 24 months Evaluate baseline differences and longitudinal changes (from baseline to month 24) in Disorganisation of Retinal Inner Layers (DRIL) assessed using Optical Coherence Tomography (OCT) across DRSS levels.
Changes in Disorganisation of Retinal Outer Layers (DROL) — Baseline to 24 months Evaluate baseline differences and longitudinal changes (from baseline to month 24) in Disorganisation of Retinal Outer Layers (DROL) assessed using Optical Coherence Tomography (OCT) across DRSS levels.
Changes in Ganglion Cell Layer (GCL) + Inner Plexiform Layer (IPL) thickness — Baseline to 24 months Evaluate baseline differences and longitudinal changes (from baseline to month 24) in Ganglion Cell Layer (GCL) + Inner Plexiform Layer (IPL) thickness assessed using Optical Coherence Tomography (OCT) across DRSS levels.
DRSS severity level — Baseline to 24 months Evaluate the DRSS score (range 10-85; higher scores indicate worse severity) in Ultra-widefield fundus photography (UWF-FP).
Changes in microaneurysm (MA) count — Baseline to 24 months Evaluate baseline differences and longitudinal changes (from baseline to months 6, 12, and 24) in MA number in colour fundus photography (CFP field 2) across DRSS levels.
Changes in microaneurysm (MA) turnover — Baseline to 24 months Evaluate baseline differences and longitudinal changes (from baseline to months 6, 12, and 24) in MA turnover in colour fundus photography (CFP field 2) across DRSS levels.
Trial sites (1)
Facility
City
Region
Status
AIBILI-CEC (AIBILI-Clinical Trial Centre)
Coimbra
Portugal
Recruiting
More Association for Innovation and Biomedical Research on Light and Image trials in Portugal
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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