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The purpose of this study is to identify eyes that show worsening and disease progression (progressor phenotypes).
To identify "progressors" in retinal vascular disease and central retinal edema in type 2 diabetic patients with early NPDR, based on retinal disease progression from baseline to the 12-month visit, assessed by the following biomarkers:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type-2 diabetes, NPDR | Type-2 diabetic patients with NPDR. |
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| Measure | Description | Time Frame |
|---|---|---|
| Identify "progressors" | To identify "progressors" in retinal vascular disease and central retinal edema, the following 2 biomarkers will be considered: the MA formation rate (biomarker for the progression of retinal vascular disease) and the presence of retinal thickening in the central subfield and/or the inner ring (biomarker for the presence of retinal edema). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Identify correlations between "progressors" and study outcomes. | To identify correlations between "progressors" and the different study outcomes. To explore the parameters, and to identify highly predictive outcomes. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Type-2 diabetes, NPDR
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| Name | Affiliation | Role |
|---|---|---|
| José Cunha-Vaz, MD PhD | Association for Innovation and Biomedical Research on Light and Image | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Trials- AIBILI - Association for Innovation and Biomedical Research on Light and Image | Coimbra | Coimbra District | 3030-548 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28785768 | Derived | Cunha-Vaz J, Ribeiro L, Costa M, Simo R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780. | |
| 27978559 | Derived | Cunha-Vaz J, Santos T, Ribeiro L, Alves D, Marques I, Goldberg M. OCT-Leakage: A New Method to Identify and Locate Abnormal Fluid Accumulation in Diabetic Retinal Edema. Invest Ophthalmol Vis Sci. 2016 Dec 1;57(15):6776-6783. doi: 10.1167/iovs.16-19999. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 26322834 | Derived | Ribeiro L, Bandello F, Tejerina AN, Vujosevic S, Varano M, Egan C, Sivaprasad S, Menon G, Massin P, Verbraak FD, Lund-Andersen H, Martinez JP, Jurgens I, Smets E, Coriat C, Wiedemann P, Agoas V, Querques G, Holz FG, Nunes S, Neves C, Cunha-Vaz J; Evicr Net Study Group. Characterization of Retinal Disease Progression in a 1-Year Longitudinal Study of Eyes With Mild Nonproliferative Retinopathy in Diabetes Type 2. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5698-705. doi: 10.1167/iovs.15-16708. |
| 26315560 | Derived | Tejerina AN, Vujosevic S, Varano M, Egan C, Sivaprasad S, Menon G, Massin P, Verbraak FD, Lund-Andersen H, Martinez JP, Jurgens I, Smets E, Coriat C, Wiedemann P, Agoas V, Querques G, Holz FG, Nunes S, Alves D, Neves C, Santos T, Ribeiro L, Bandello F, Cunha-Vaz J; for EVICR.net. One-year progression of diabetic subclinical macular edema in eyes with mild nonproliferative diabetic retinopathy: location of the increase in retinal thickness. Ophthalmic Res. 2015;54(3):118-23. doi: 10.1159/000438793. Epub 2015 Aug 21. |
| 26315448 | Derived | Bandello F, Tejerina AN, Vujosevic S, Varano M, Egan C, Sivaprasad S, Menon G, Massin P, Verbraak FD, Lund-Andersen H, Martinez JP, Jurgens I, Smets RM, Coriat C, Wiedemann P, Agoas V, Querques G, Holz FG, Nunes S, Alves D, Neves C, Santos T, Ribeiro L, Cunha-Vaz J; EVICR.net. Retinal layer location of increased retinal thickness in eyes with subclinical and clinical macular edema in diabetes type 2. Ophthalmic Res. 2015;54(3):112-7. doi: 10.1159/000438792. Epub 2015 Aug 21. |
| D004700 | Endocrine System Diseases |