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Genetic Markers and Proliferative Diabetic Retinopathy (REDIAGEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02879422
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : February 25, 2019
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Diabetic patients with proliferative diabetic retinopathy Genetic: genetic analysis
Diabetic patients with non proliferative diabetic retinopathy Genetic: genetic analysis

Primary Outcome Measures :
  1. Proliferative retinopathy diabetic [ Time Frame: Day 0 ]
    diabetic retinopathy with a preretinal and / or prepapillary neovascularization diagnosed using ultra-wide-field imaging

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • type 2 diabetic patients
  • patient with proliferative diabetic retinopathy (for arm 1)
  • patient with non proliferative diabetic retinopathy (for arm 2)
  • patient older than 18 years
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program

Information from the National Library of Medicine

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 identifier (NCT number): NCT02879422

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Contact: Carl ARNDT
Contact: Vincent DURLACH

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Chu de Reims Recruiting
Reims, France, 51092
Contact: Carl ARNDT   
Contact: Vincent DURLACH   
Sponsors and Collaborators
CHU de Reims

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Responsible Party: CHU de Reims Identifier: NCT02879422     History of Changes
Other Study ID Numbers: PR12040
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases