NCT05581225Active, not recruiting
Prediction of Progression of Retinal Ischemia in Diabetes
Source: ClinicalTrials.gov · Last updated 9 May 2025
Brief summary (registry, in English)
Diabetes Mellitus (DM) is a major public health problem with significant socioeconomic implications due to its increased prevalence. Diabetic retinopathy (DR) is the most frequent complication in DM patients and remains the leading cause of legal blindness in working-age populations (Yau et al., 2012). Differentiating patients with higher vs low risk of progression to vision-threatening complications is of paramount importance for an efficient managing of the disease to prevent vision disability. PREDICTION is a longitudinal prospective clinical study in DMT2 patients with a higher risk of progression to explore possible imaging, functional and systemic biomarkers of progression, using non-invasive methods, commonly applied in the clinical practice. Investigating the retinal vascular network (vessel density metrics with Optical Coherence Tomography Angiography) will allow a better understanding of the evolution of capillary closure and ischemia, two main risk factors for DR worsening.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 62 (actual)
- First submitted
- 12 Oct 2022
- Start date
- 2 Dec 2022
- Primary completion date
- 2 Feb 2024
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Diseases
- Diabetic eye disease
- NCT number
- NCT05581225
What you commit to
- Study type: Observational
- Participants enrolled: 62
- From 2 Dec 2022 to the primary completion date, 2 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any eye surgery within a period of 6-months before the inclusion visit date.
- Previous laser or intravitreal injection treatment.
Other illness
- Cataract or other eye disease that may interfere with fundus examinations.
- Other retinal vascular disease.
Lab values
- HBA1C ≥ 12%
Other
- Dilatation of the pupil \< 5 mm.
Who the study is looking for
- DM type 2 according to 1985 WHO criteria.
- Age between 35 and 80 years.
- BCVA ≥ 75 letters (20 /32).
- Refraction with a spherical equivalent less than 5 Diopters.
- NPDR levels 43, 47 or 53 (based on the ETDRS criteria - 7 fields CFP).
Age in the registry: 35 years to 80 years · Sex: All
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AIBILI-CEC (AIBILI- Clinical Trials Centre) Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.