Phenotyping Diabetic Retinopathy
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Observational Study of Type-2 Diabetic Subjects to Validate Diabetic Retinopathy Phenotypes|
- CSME [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Type-2 diabetic subjects diagnosed with diabetic retinopathy (DR).
This study aims to validate and characterize phenotypes of diabetic retinopathy (DR) progression using ophthalmic and systemic data from type-2 diabetic subjects followed at the AIBILI Clinical Trial Center in the last 10 years.
Macular Edema (ME) development during the study period, mainly Clinically Significant ME (CSME) needing treatment, will be the primary indicator for DR progression. CSME will be considered as the primary end-point and will be used to identify phenotypes (and risk markers) of DR progression.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840541
|AIBILI - Clinical Trial Center|
|Coimbra, Portugal, 3000-548|
|Principal Investigator:||José Cunha-Vaz, MD PhD||Association for Innovation and Biomedical Research on Light and Image|