Investigating early retinal changes as indicators and targets for diabetic eye disease
Early Retinal Neurodegeneration As Risk Factor, Biomarker and Pharmacological Target of Diabetic Retinopathy
This study is trying to see if early changes in the retina can help predict and understand the development of diabetic eye disease in people with type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | IRCCS Ospedale San Raffaele Academic / other |
| Locations | 2 sites (Milan, Italy/milan and 1 other locations) |
| Trial ID | NCT06582472 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between early retinal neurodegeneration and the development of diabetic retinopathy (DR) in patients with type 2 diabetes. It includes a longitudinal study that will follow type 2 diabetic patients without DR over two years to assess the risk of developing retinal microaneurysms, and a cross-sectional study comparing patients with long-standing diabetes with and without DR. The study will utilize various ophthalmological assessments and biological sampling to gather data on retinal health and inflammation.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 40-80 with type 2 diabetes for less than 10 years without retinopathy, as well as those with a long history of diabetes with or without DR.
Not a fit: Patients with type 2 diabetes who are younger than 40 or older than 80, or those with significant diabetic complications other than retinopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early identification and potential treatment strategies for diabetic retinopathy, reducing the risk of blindness in diabetic patients.
How similar studies have performed: While the concept of neurodegeneration as a precursor to diabetic retinopathy is emerging, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria - Longitudinal study (patients): 1. Participant is willing and able to give informed consent for participation in the trial. 2. Male or Female, aged 40 - 80 years; 3. In good general health as evidenced by medical history or diagnosed with type 2 diabetes for less than 10 years without clinical signs of retinopathy and other diabetic complications; 4. HbA1c level 7% or greater; Inclusion Criteria - Longitudinal study (healthy controls) 1. Participant is willing and able to give informed consent for participation in the trial; 2. Male or Female, aged 40 - 80 years; 3. In good general health as evidenced by medical history without diagnosis of type 2 diabetes; Inclusion Criteria - Cross-sectional study 1. Participant is willing and able to give informed consent for participation in the trial; 2. Male or Female, aged 40 - 80 years; 3. Patient with a diagnosis of type 2 diabetes for longer than 20 years in the absence or presence of clinical signs of retinopathy and other diabetic complications; 4. HbA1c level 7% or greater. Exclusion Criteria (longitudinal study and cross-sectional study) An individual who meets any of the following criteria will be excluded from participation in this study: 1. retinal or systemic diseases other than diabetes; 2. hypertension (BP values greater than 140/90 mm Hg); 3. anemia (hematocrit less than 35%); 4. smoking; 5. laser treatment and pregnancy
Where this trial is running
Milan, Italy/milan and 1 other locations
- Irccs Ospedale San Raffaele — Milan, Italy/milan, Italy (Recruiting)
- IRCCS Ospedale San Raffaele _O.U. Ophthalmology — Milan, Italy, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.