Tracking retinal changes over two years in people with moderate to early proliferative diabetic retinopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-year longitudinal observational project enrolling adults with type 2 diabetes who have moderate to severe non-proliferative diabetic retinopathy or mild proliferative disease. Participants will undergo serial retinal imaging (including ultra-widefield fundus imaging and OCT), visual function testing, and systemic biomarker sampling at scheduled visits using widely used clinical methods. The study will map changes in retinal structure, perfusion, and molecular markers to identify patterns that precede progression to proliferative disease or diabetic macular edema. Longitudinal data aim to support better timing of interventions to prevent vision loss.

Why it matters

Who can join: the full rules

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.

Where it's running

• AIBILI-CEC (AIBILI-Clinical Trial Centre)
  Coimbra, Portugal Recruiting

Study contacts

• Principal investigator: Inês P Marques, MD PhD — AIBILI - Associação para a Investigação Biomédica e Inovação em Luz e Imagem
• Study coordinator: Joana Tavares, PhD
• Email: jftavares@aibli.pt
• Phone: +351239480137

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.