Actively Recruiting
Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients
Led by Association for Innovation and Biomedical Research on Light and Image · Updated on 2026-03-11
100
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
Sponsors
A
Association for Innovation and Biomedical Research on Light and Image
Lead Sponsor
F
Fundação para a Ciência e a Tecnologia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Type 2 diabetes mellitus diagnosed according to 1985 WHO criteria
- Age between 35 and 80 years
- Best-corrected visual acuity (BCVA) of 69 letters or better (20/40 vision)
- Refraction with spherical equivalent less than 5 diopters
- Moderate to severe non-proliferative diabetic retinopathy (DRSS levels 43, 47, 53) or mild proliferative diabetic retinopathy (DRSS level 61) where treatment can be safely delayed for at least 6 months
- Ability to understand and sign the written informed consent form
You will not qualify if you...
- Central subfield thickness (CST) greater than 400 micrometers (fluid allowed if CST is 400 micrometers or less with normal foveal contour and no immediate treatment needed)
- Any signs of retinal fibrovascular proliferation
- Uncontrolled glaucoma with intraocular pressure over 25 mmHg
- Presence of iris neovascularization, vitreous, or pre-retinal hemorrhage
- Other retinal vascular diseases such as ocular ischemic syndrome, retinal arterial or venous occlusion, or exudative age-related macular degeneration
- Previous panretinal photocoagulation or intravitreal injection treatment
- Eye surgery within 6 months before the study visit
- Significant media opacities like severe cataract, corneal scarring or edema, or vitreous hemorrhage that prevent fundus evaluation
- Pupil dilation less than 5 mm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AIBILI-CEC (AIBILI-Clinical Trial Centre)
Coimbra, Portugal, 3000-548
Actively Recruiting
Research Team
J
Joana Tavares, PhD
CONTACT
L
Liliana C Soares, MsC
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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