Genetic Markers and Proliferative Diabetic Retinopathy
REDIAGEN
Study of the Association Between Genetic Markers (Endothelial Lipase and Aldose Reductase) and Proliferative Diabetic Retinopathy
1 other identifier
interventional
302
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2013
CompletedFirst Submitted
Initial submission to the registry
August 22, 2016
CompletedFirst Posted
Study publicly available on registry
August 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedJanuary 21, 2026
February 1, 2021
6.4 years
August 22, 2016
January 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proliferative retinopathy diabetic
diabetic retinopathy with a preretinal and / or prepapillary neovascularization diagnosed using ultra-wide-field imaging
Day 0
Study Arms (2)
Diabetic patients with proliferative diabetic retinopathy
OTHERDiabetic patients with non proliferative diabetic retinopathy
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Reimslead
Study Sites (1)
Chu de Reims
Reims, 51092, France
Related Publications (1)
Henry A, Boigelot T, Moura TF, Leclercq I, Barbe C, Thiery A, Djerada Z, Nazeyrollas P, Clavel C, Cornillet-Lefebvre P, Berrod JP, Creuzot-Garcher C, Meyer L, Gaucher D, Guerci B, Lenoble P, Milazzo S, Perone JM, Arndt C, Durlach V. No association of endothelial lipase and aldose reductase polymorphisms with proliferative diabetic retinopathy: Results of the French prospective multicenter REDIAGEN study. Diabetes Metab. 2024 May;50(3):101533. doi: 10.1016/j.diabet.2024.101533. Epub 2024 Apr 1. No abstract available.
PMID: 38570135RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2016
First Posted
August 25, 2016
Study Start
October 16, 2013
Primary Completion
March 3, 2020
Study Completion
January 1, 2021
Last Updated
January 21, 2026
Record last verified: 2021-02