Genetic Markers and Proliferative Diabetic Retinopathy (REDIAGEN)

January 19, 2026 updated by: CHU de Reims

Study of the Association Between Genetic Markers (Endothelial Lipase and Aldose Reductase) and Proliferative Diabetic Retinopathy

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • CHU de Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Diabetic patients with proliferative diabetic retinopathy
Genetic: genetic analysis
Other: Diabetic patients with non proliferative diabetic retinopathy
Genetic: genetic analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proliferative retinopathy diabetic
Time Frame: Day 0
diabetic retinopathy with a preretinal and / or prepapillary neovascularization diagnosed using ultra-wide-field imaging
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2013

Primary Completion (Actual)

March 3, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimated)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR12040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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