Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04650165
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2020-11-25
Brief Title:
10-year Progression of Diabetic Retinopathy Identification of Signs and Surrogate Outcomes
Sponsor:
Association for Innovation and Biomedical Research on Light and Image
Organization:
Association for Innovation and Biomedical Research on Light and Image
Study Overview
Official Title:
10-year Progression of Diabetic Retinopathy Identification of Signs and Surrogate Outcomes
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROGRESS10
Brief Summary:
To characterize both functionally and morphologically initial Diabetic Retinopathy DR stages and their progression over a period of 10 years
Detailed Description:
Diabetic retinopathy DR is the most frequent complication of diabetes mellitus and the leading cause of legal blindness in active populations of industrialized countries Progression of DR has been up to now classified according to the ETDRS classification based on a multicentric study that evaluated the effect of laser photocoagulation on advanced stages of DR Although appropriate for late stages of DR it does not grade progression well in the initial stages of the disease Initial stages of DR require urgent characterization and their evolution should be well defined because some of the lesions are still reversible
The early stages of DR are characterized by 4 main alterations microaneurysms MA and retinal hemorrhages represented by red dots in the fundus blood-retinal barrier breakdown capillary closure and damage of neuronal and glial cells of the retina Thus there are both microvascular changes with endothelial cell and pericyte damage with thickening of basement membrane and neuronal changes
Based on previous studies progression of DR does not occur at the same rate in all patients Some never develop vision loss whereas others rapidly progress to macular edema or neovascularization leading to vision loss The understanding of the mechanisms that balance in different direction is of outmost importance The duration of diabetes mellitus and the metabolic control are major risk factors for DR progression but they are insufficient to explain the great variability observed in patients
Recent data indicate that MA turnover may be an appropriate indicator of DR progression Our research group has identified different DR progression phenotypes Phenotype A is characterized by a low MA turnover phenotype B characterized by increased thickness and phenotype C with predominant ischemia with a high MA turnover These phenotypes were defined based on MA turnover RetmarkerDR and on central retinal thickness RT measured by Optical Coherence Tomography OCT and the model was able to correctly identify eyes at risk of progression 618-767 of eyes with an increase RT in the central subfield inner andor outer ring allowed a MA formation rate 2 andor a MA turnover 6 More recently some genetic variants have been linked to the different phenotypes and may explain specific progression patterns
There is emerging evidence to suggest that retinal neurodegeneration is an early event in the pathogenesis of DR and that it could participate in the development of microvascular abnormalities The understanding of the underlying mechanisms leading to neurodegeneration and the identification of the mediators between neurodegeneration and microangiopathy is essential
The Investigators aim to understand the extent of these cell abnormalities in the initial stages of DR and to characterize their progression
Analysis of retinal thickness using OCT offers non-invasive evaluation of retinal edema and can suggest an appropriate treatment target The Investigators will use recent and innovative approaches as Spectral domain OCT SD-OCT with retinal layers segmentation to study neurodegenerative changes occurring in DR OCT-Angiography and OCT-Leakage layer by layer analysis will be used for microvasculature and blood retinal barrier assessment
The early stages of DR are characterized by 4 main alterations microaneurysms MA and retinal hemorrhages represented by red dots in the fundus blood-retinal barrier breakdown capillary closure and damage of neuronal and glial cells of the retina Thus there are both microvascular changes with endothelial cell and pericyte damage with thickening of basement membrane and neuronal changes
Based on previous studies progression of DR does not occur at the same rate in all patients Some never develop vision loss whereas others rapidly progress to macular edema or neovascularization leading to vision loss The understanding of the mechanisms that balance in different direction is of outmost importance The duration of diabetes mellitus and the metabolic control are major risk factors for DR progression but they are insufficient to explain the great variability observed in patients
Recent data indicate that MA turnover may be an appropriate indicator of DR progression Our research group has identified different DR progression phenotypes Phenotype A is characterized by a low MA turnover phenotype B characterized by increased thickness and phenotype C with predominant ischemia with a high MA turnover These phenotypes were defined based on MA turnover RetmarkerDR and on central retinal thickness RT measured by Optical Coherence Tomography OCT and the model was able to correctly identify eyes at risk of progression 618-767 of eyes with an increase RT in the central subfield inner andor outer ring allowed a MA formation rate 2 andor a MA turnover 6 More recently some genetic variants have been linked to the different phenotypes and may explain specific progression patterns
There is emerging evidence to suggest that retinal neurodegeneration is an early event in the pathogenesis of DR and that it could participate in the development of microvascular abnormalities The understanding of the underlying mechanisms leading to neurodegeneration and the identification of the mediators between neurodegeneration and microangiopathy is essential
The Investigators aim to understand the extent of these cell abnormalities in the initial stages of DR and to characterize their progression
Analysis of retinal thickness using OCT offers non-invasive evaluation of retinal edema and can suggest an appropriate treatment target The Investigators will use recent and innovative approaches as Spectral domain OCT SD-OCT with retinal layers segmentation to study neurodegenerative changes occurring in DR OCT-Angiography and OCT-Leakage layer by layer analysis will be used for microvasculature and blood retinal barrier assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None