Proliferative Diabetic RetinopathyREDIAGENNCT02879422
Genetic Markers and Proliferative Diabetic Retinopathy
A study testing genetic analysis in people with Proliferative Diabetic Retinopathy, run by CHU de Reims at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- genetic analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2013to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the 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.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- genetic analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic analysisGenetic
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients with proliferative diabetic retinopathy | Other | Not described Receives: Genetic: genetic analysis |
| Diabetic patients with non proliferative diabetic retinopathy | Other | Not described Receives: Genetic: genetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proliferative retinopathy diabetic
diabetic retinopathy with a preretinal and / or prepapillary neovascularization diagnosed using ultra-wide-field imaging
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start16 Oct 2013
- Primary completion3 Mar 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879422
- Sponsor's protocol ID
- PR12040
- Acronym
- REDIAGEN
- Status last verified
- Feb 2021
- First submitted
- 22 Aug 2016
- Last updated
- 21 Jan 2026
- Results posted
- No
Publications
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.
PubMed 38570135
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Association Between Genetic Markers (Endothelial Lipase and Aldose Reductase) and Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT02879422
- Acronym / sponsor ID
- REDIAGEN / PR12040
- Conditions
- Proliferative Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 16 Oct 2013 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients with proliferative diabetic retinopathy | Other | Genetic: genetic analysis |
| Diabetic patients with non proliferative diabetic retinopathy | Other | Genetic: genetic analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic analysis | Genetic | Diabetic patients with non proliferative diabetic retinopathy, Diabetic patients with proliferative diabetic retinopathy |
Primary outcome
Proliferative retinopathy diabetic
Time frame: Day 0
diabetic retinopathy with a preretinal and / or prepapillary neovascularization diagnosed using ultra-wide-field imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Results publication: PubMed 38570135Henry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing genetic analysis in people with Proliferative Diabetic Retinopathy, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proliferative retinopathy diabetic (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02879422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.