Genetic Markers and Proliferative Diabetic Retinopathy (REDIAGEN)
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|ClinicalTrials.gov Identifier: NCT02879422|
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : October 17, 2017
Type 2 Diabetes (TD2) is the leading cause of new cases of preventable blindness in these countries (and the gold-standard treatment, laser photocoagulation has proven to be effective in preventing vision loss at the end stage of eye disease due to proliferative diabetic retinopathy (PDR) that occurs in 3 to 6 % of the cases.Therefore, the ongoing search for predictive factors of sight threatening stages of diabetic retinopathy has become more important.
Previous studies that have examined candidate predictive factors for diabetic eye disease have mostly focused on systemic risk factors leading to PDR. Among various clinical parameters, increased HbA1c % levels, uncontrolled blood pressure, diabetes duration, neuropathy and elevated triglycerides have been associated with PDR.
Some genetic factors may also account for the development of PDR and are prospectively considered in this study .
|Condition or disease||Intervention/treatment||Phase|
|Proliferative Diabetic Retinopathy||Genetic: genetic analysis||Not Applicable|
In a previous study (2011), investigators demonstrated a statistically significant relation between the Endothelial Lipase(EL) c.584C>T polymorphism and the occurrence of diabetic retinopathy in 396 french patients with diabetes type 2 (DT2) with a longitudinal follow-up.
Secondly (2014) in a subgroup of 287 DT2 patients, investigators showed the impact of the EL rare T allele was consistent with a recessive mode of inheritance, with homozygotes for the rare allele differing from the carriers of the major allele. Importantly, the homozygotes for the rare T allele were more likely to present with advanced stages of diabetic retinopathy (severe non proliferative and proliferative disease) and particularly with proliferative diabetic retinopathy (PDR).
Based on this model investigators decided to conduct a case-control prospective study comparing 155 french patients with DT2 with PDR (cases) and 155 french patients with DT2 without PDR (controls) on the basis of two genetic parameters: EL c.584C>T polymorphism that investigators previously studied and the C(-106)T aldose reductase polymorphism widely studied in diabetic retinopathy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||310 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Study of the Association Between Genetic Markers (Endothelial Lipase and Aldose Reductase) and Proliferative Diabetic Retinopathy|
|Actual Study Start Date :||October 16, 2013|
|Estimated Primary Completion Date :||October 16, 2019|
|Estimated Study Completion Date :||April 2022|
|Diabetic patients with proliferative diabetic retinopathy||
Genetic: genetic analysis
|Diabetic patients with non proliferative diabetic retinopathy||
Genetic: genetic analysis
- Proliferative retinopathy diabetic [ Time Frame: Day 0 ]diabetic retinopathy with a preretinal and / or prepapillary neovascularization diagnosed using ultra-wide-field imaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879422
|Chu de Reims||Recruiting|
|Reims, France, 51092|
|Contact: Carl ARNDT email@example.com|
|Contact: Vincent DURLACH firstname.lastname@example.org|