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| Name | Class |
|---|---|
| University of Coimbra | OTHER |
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To characterise phenotypes of Non Proliferative Diabetic Retinopathy (NPDR) progression using multimodal testing/imaging procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leaking Phenotype | Retinal thickness (RT) increase (increase in RT above normal range as measured by OCT, considering the macular thickness normative data) in the central subfield, the inner ring and/or the outer ring. | ||
| Ischemic Phenotype | Neovascular disease activity as shown by microaneurysms (MA) turnover (MA formation rate >= 2, i.e. number of new MA per year) computed from CFP using the RetmarkerDR software. |
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| Measure | Description | Time Frame |
|---|---|---|
| Multimodal testing/imaging procedures - Ophthalmological Imaging | Retinal thickness measured with OCT; | 24 months |
| Multimodal testing/imaging procedures - Ophthalmological Imaging | MA turnover computed based on CFP. | 24 months |
| Multimodal testing/imaging procedures - Ophthalmological Imaging | Macular area with increased retinal fluorescein leakage based on RLA. | 12 months |
| Multimodal testing/imaging procedures - Ophthalmological Imaging | Implicit time local and ring amplitudes measured with mfERG. | 12 months |
| Multimodal testing/imaging procedures - Psychophysical Testing | Psychophysical tests for speed discrimination, achromatic contrast, and chromatic contrast. | 12 months |
| Multimodal testing/imaging procedures - Barin Imaging | Perfusion change measured with ASL. | 12 months |
| Multimodal testing/imaging procedures - Ophthalmological Imaging | Blood-Brain Barrier alterations assessed contrast agent with Dynamic MR. | 12 months |
| Multimodal testing/imaging procedures - Brain Imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Multimodal testing/ imaging modalities (raw data) | Raw data obtained from the different modalities (OCT,MA turnover, RLA,mfERG, psychophysical tests, ASL, Dynamic MR and MR Spectroscopy). | 24 months |
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Inclusion Criteria:
Age over 18 years-old.
Diabetes mellitus type 2 according to 1985 WHO criteria.
Non-proliferative diabetic retinopathy (ETDRS level <= 35)
Signs of NPDR progression based on existing clinical information:
Informed consent.
Exclusion Criteria:
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The study population will consist of 20 patients, male and female over 18 years-old, with type-2 diabetes mellitus and NPDR with signs of DR progression (RT increase and/or MA turnover) (according to the inclusion/exclusion criteria).
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| Name | Affiliation | Role |
|---|---|---|
| José Cunha-Vaz, MD PhD | Association for Innovation and Biomedical Research on Light and Image | Study Chair |
| Miguel Castelo-Branco, MD PhD | FMUC | Study Chair |
| Luísa Ribeiro, MD MSc | AIBILI - CEC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIBILI - Clinical Trials Centre (CEC) | Coimbra | 3000-548 | Portugal |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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Metabolite concentrations assessed with MR Spectroscopy.
| 12 months |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |