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Early Retinal Neurodegeneration As Risk Factor, Biomarker and Pharmacological Target of Diabetic Retinopathy
Led by IRCCS Ospedale San Raffaele · Updated on 2024-09-03
180
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating diabetic retinopathy (DR), a leading cause of blindness among working-age adults, focusing on early retinal neurodegeneration as a possible risk factor and biomarker for the disease. This observational study aims to clarify whether nerve cell damage in the retina contributes to later vascular problems seen in DR, which could open new avenues for treatment. The study includes two parts: a longitudinal follow-up of type 2 diabetes patients without DR, and a cross-sectional comparison of patients with long-standing diabetes with and without DR. The study involves detailed eye examinations and sample collections using advanced imaging techniques such as Optical Coherence Tomography (OCT), OCT Angiography (OCT-A), and Dynamic Vessel Analyzer (DVA). Procedures include confocal microscopy of the cornea, tear and blood sample collection for biomarker analysis, and conjunctival impression cytology. The longitudinal study will follow 120 participants (90 diabetic patients and 30 healthy controls) over 24 months with visits every six months. The cross-sectional study will include 60 participants with diabetes for over 20 years undergoing a single evaluation. Participants will undergo periodic ophthalmological assessments and laboratory tests to monitor retinal changes and inflammation markers. Researchers will analyze these data to understand the relationship between early neurodegeneration and diabetic retinopathy development. The study measures include imaging assessments, confocal microscopy, blood and tear sample analyses, with monitoring over two years for the longitudinal group. This comprehensive approach aims to identify early signs of DR and better understand its progression, with participant involvement lasting up to two years.
CONDITIONS
Brief Title
Early Retinal Neurodegeneration As Risk Factor, Biomarker and Pharmacological Target of Diabetic Retinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is willing and able to give informed consent for participation in the trial
- Male or Female, aged 40 - 80 years
- In good general health or diagnosed with type 2 diabetes for less than 10 years without clinical signs of retinopathy and other diabetic complications (longitudinal study patients)
- HbA1c level 7% or greater (longitudinal study patients and cross-sectional study participants)
- In good general health without diagnosis of type 2 diabetes (longitudinal study healthy controls)
- Diagnosis of type 2 diabetes for longer than 20 years with or without clinical signs of retinopathy and other diabetic complications (cross-sectional study)
You will not qualify if you...
- Presence of retinal or systemic diseases other than diabetes
- High blood pressure (BP values greater than 140/90 mm Hg)
- Anemia (hematocrit less than 35%)
- Smoking
- Previous laser treatment
- Pregnancy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants undergo ophthalmological examinations, imaging assessments, confocal analysis of the cornea, Dynamic Vessel Analyzer measurements, tear sampling, and blood sampling to observe retinal neurodegeneration and vascular changes associated with diabetic retinopathy.
Visits at baseline, month 6, month 12, month 18, and month 24 for longitudinal study participants; 1 visit for cross-sectional study participants
Trial Site Locations
Total: 2 locations
1
Irccs Ospedale San Raffaele
Milan, Italy/milan, Italy, 20132
Actively Recruiting
2
IRCCS Ospedale San Raffaele _O.U. Ophthalmology
Milan, Italy, Italy, 20123
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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