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Effect of OMEGA3 Supplementation in Diabetic Retinopathy (OMEDIA)

Primary Purpose

Diabetic Retinopathy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nutrof
Meralut
Sponsored by
Centre Hospitalier Intercommunal Creteil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥18 years
  • For women of childbearing age, an effective method of contraception is introduced and monitored throughout their participation in the study.
  • Diabetic microangiopathy: minimal to moderate nonproliferative diabetic retinopathy according to the ETDRS (EarlyTreatment of DiabeticRetinopathyStudy) classification.
  • AV > 6/10
  • One eye included. If both are affected, the eye with the poorer perfusion should be included.
  • Affiliated to a social security scheme

Exclusion Criteria:

  • < 18 years old.
  • Pregnant or breastfeeding woman
  • Other retinal pathologies that may interfere with the results (Patients previously treated with anti-VEGF, aflibercept or intra-vitreal corticosteroids, history of glaucoma, vitrectomy, retinal laser, epiretinal membrane), choroidal neo-vascularization, uveitis, retinal vascular occlusion, significant macular edema, macular thickness > 280 µm, Eyes with spherical equivalent greater than 8 Diopters, OCTA images not interpretable with many artifacts.)
  • Hypersensitivity to any of the components of Nutrof or Meralut
  • Taking the antivitamin k
  • Known deficit in G6PD-
  • History of renal lithiasis
  • Kidney failure
  • Immunosuppression
  • Chronic Ethylism
  • History of hepatopathy
  • Intracranial tumor, intracranial hypertension
  • Refusal to participate
  • Patient participating in an intervention study.

Sites / Locations

  • CHI CreteilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NUTROF Group

MERALUT Group

Arm Description

vitamin and DHA supplementation

vitamin A, natural flavonoids, lutein and zeaxanthin and no DHA

Outcomes

Primary Outcome Measures

density of the deep capillary plexus in optical coherence tomography angiography (OCTA)
Macular vascularization consists of three interconnected capillary plexuses: the superficial capillary plexus (SCp) located at the level of the optic fibres and the intermediate (ICP) and deep (DCP) capillary plexuses located respectively at the level of the inner and outer part of the inner nuclear layer.16 OCTA is a non-invasive imaging method of retinal vasculature that allows a qualitative but mainly quantitative analysis of the capillary plexuses. A last parameter that could not be evaluated precisely with the old fluorescein and OCT angiography techniques. OCTA is performed without injection of intravenous contrast agent and has no side effects. Several studies have shown that PCP is the plexus most affected by non-perfusion areas in diabetic retinopathy.

Secondary Outcome Measures

capillary plexus density in OCTA
capillary plexus density
area (mm²) of the central avascular zone in OCTA
area (mm²
Visual acuity measurement ETDRS
Visual acuity
Stage of diabetic retinopathy: minimal, moderate or severe
Each stage of retinopathy may be associated with some degree of diabetic macular edema; macular edema is classified as minimal, moderate or severe, depending on its location relative to the centre of the macula. It is considered severe when it reaches the centre of the macula. Non-proliferative diabetic retinopathy (NPDR, no neo-vessels) Minimal non-proliferative DR (some microaneurysms or punctiform hemorrhages). Moderate nonproliferative DR (by exclusion if neither minimal nor severe DRNP) Severe nonproliferative DR (or preproliferative DR): "4, 2, 1" rule (retinal hemorrhages in 4 quadrants and/or venous dilatations in 2 quadrants and/or AMIR in 1 quadrant)
central retinal thickness (µm) in the 2 groups at 6 months
central retinal thickness
cholesterol level: Low-density lipoprotein, High-density lipoprotein and total cholesterol
cholesterol leve
triglycerid level
triglycerid level
glycated haemoglobin (percent)
In diabetes, the higher the blood glucose level, the more glucose attaches to hemoglobin and the higher the level of glycated hemoglobin. It therefore indicates whether the blood glucose level was, on average, higher or lower during the 2 months prior to the test. Glycated haemoglobin is measured every 2-4 months. A small amount of blood is drawn from a vein or from the fingertip (micro-method). Glycated haemoglobin (HbA1c) is a fundamental criterion for blood sugar control. It is essential for assessing the risk of complications. 9% Very high 7% Recommended 5% Normal
Diet questionnaire
questionnaire

Full Information

First Posted
July 3, 2020
Last Updated
December 14, 2022
Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Laboratoires Thea
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1. Study Identification

Unique Protocol Identification Number
NCT04499820
Brief Title
Effect of OMEGA3 Supplementation in Diabetic Retinopathy
Acronym
OMEDIA
Official Title
Effet d'Une supplémentation Par OMEGA3 Dans la rétinopathie diabétique
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2020 (Actual)
Primary Completion Date
June 25, 2024 (Anticipated)
Study Completion Date
November 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Laboratoires Thea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study is to evaluate the efficacy at 6 months of omega 3 supplementation on macular capillary density measured in optical coherence tomography angiography in patients with minimal or moderate non proliferative diabetic retinopathy.
Detailed Description
Diabetic retinopathy (DR) is a leading cause of vision loss worldwide and is a major public health problem. In Western countries, the prevalence of DR is estimated to be 35% in diabetic patients, while diabetic macular edema (DME) affects 5% of them. Currently, apart from the balance of diabetes and other cardiovascular risk factors, no specific treatment is given for the minimal and moderate non-proliferative forms. DHA concentration in the retina can be modified according to the patient's diet. Minimal diabetic retinopathy does not currently benefit from specific treatment outside of diabetic control. Omega 3 are already known for their beneficial effects on the retina, brain and cardiovascular system but their effectiveness has not been tested on diabetic retinopathy. It is therefore a question of evaluating whether an omega 3 supplementation, at a dosage of 1000mg per day, can treat a minimal or moderate stage of diabetic retinopathy. A study by Salavila et al. has shown that the intake of LCω3PUFA, via a Mediterranean diet, improved the stage of DR in diabetic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NUTROF Group
Arm Type
Experimental
Arm Description
vitamin and DHA supplementation
Arm Title
MERALUT Group
Arm Type
Placebo Comparator
Arm Description
vitamin A, natural flavonoids, lutein and zeaxanthin and no DHA
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrof
Intervention Description
DHA docosahexaenoic acid Omega 3s may be of interest in cases of retinopathies.
Intervention Type
Dietary Supplement
Intervention Name(s)
Meralut
Intervention Description
vitamin A, natural flavonoids, lutein and zeaxanthin
Primary Outcome Measure Information:
Title
density of the deep capillary plexus in optical coherence tomography angiography (OCTA)
Description
Macular vascularization consists of three interconnected capillary plexuses: the superficial capillary plexus (SCp) located at the level of the optic fibres and the intermediate (ICP) and deep (DCP) capillary plexuses located respectively at the level of the inner and outer part of the inner nuclear layer.16 OCTA is a non-invasive imaging method of retinal vasculature that allows a qualitative but mainly quantitative analysis of the capillary plexuses. A last parameter that could not be evaluated precisely with the old fluorescein and OCT angiography techniques. OCTA is performed without injection of intravenous contrast agent and has no side effects. Several studies have shown that PCP is the plexus most affected by non-perfusion areas in diabetic retinopathy.
Time Frame
six months
Secondary Outcome Measure Information:
Title
capillary plexus density in OCTA
Description
capillary plexus density
Time Frame
six months
Title
area (mm²) of the central avascular zone in OCTA
Description
area (mm²
Time Frame
six months
Title
Visual acuity measurement ETDRS
Description
Visual acuity
Time Frame
six months
Title
Stage of diabetic retinopathy: minimal, moderate or severe
Description
Each stage of retinopathy may be associated with some degree of diabetic macular edema; macular edema is classified as minimal, moderate or severe, depending on its location relative to the centre of the macula. It is considered severe when it reaches the centre of the macula. Non-proliferative diabetic retinopathy (NPDR, no neo-vessels) Minimal non-proliferative DR (some microaneurysms or punctiform hemorrhages). Moderate nonproliferative DR (by exclusion if neither minimal nor severe DRNP) Severe nonproliferative DR (or preproliferative DR): "4, 2, 1" rule (retinal hemorrhages in 4 quadrants and/or venous dilatations in 2 quadrants and/or AMIR in 1 quadrant)
Time Frame
six months
Title
central retinal thickness (µm) in the 2 groups at 6 months
Description
central retinal thickness
Time Frame
six months
Title
cholesterol level: Low-density lipoprotein, High-density lipoprotein and total cholesterol
Description
cholesterol leve
Time Frame
six months
Title
triglycerid level
Description
triglycerid level
Time Frame
six months
Title
glycated haemoglobin (percent)
Description
In diabetes, the higher the blood glucose level, the more glucose attaches to hemoglobin and the higher the level of glycated hemoglobin. It therefore indicates whether the blood glucose level was, on average, higher or lower during the 2 months prior to the test. Glycated haemoglobin is measured every 2-4 months. A small amount of blood is drawn from a vein or from the fingertip (micro-method). Glycated haemoglobin (HbA1c) is a fundamental criterion for blood sugar control. It is essential for assessing the risk of complications. 9% Very high 7% Recommended 5% Normal
Time Frame
six months
Title
Diet questionnaire
Description
questionnaire
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥18 years For women of childbearing age, an effective method of contraception is introduced and monitored throughout their participation in the study. Diabetic microangiopathy: minimal to moderate nonproliferative diabetic retinopathy according to the ETDRS (EarlyTreatment of DiabeticRetinopathyStudy) classification. AV > 6/10 One eye included. If both are affected, the eye with the poorer perfusion should be included. Affiliated to a social security scheme Exclusion Criteria: < 18 years old. Pregnant or breastfeeding woman Other retinal pathologies that may interfere with the results (Patients previously treated with anti-VEGF, aflibercept or intra-vitreal corticosteroids, history of glaucoma, vitrectomy, retinal laser, epiretinal membrane), choroidal neo-vascularization, uveitis, retinal vascular occlusion, significant macular edema, macular thickness > 280 µm, Eyes with spherical equivalent greater than 8 Diopters, OCTA images not interpretable with many artifacts.) Hypersensitivity to any of the components of Nutrof or Meralut Taking the antivitamin k Known deficit in G6PD- History of renal lithiasis Kidney failure Immunosuppression Chronic Ethylism History of hepatopathy Intracranial tumor, intracranial hypertension Refusal to participate Patient participating in an intervention study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric SOUIED, MD PhD
Phone
01 45 17 50 00
Email
eric.souied@chicreteil.Fr
First Name & Middle Initial & Last Name or Official Title & Degree
Camille JUNG, MD
Phone
01 45 17 50 00
Email
camille.jung@chicreteil.fr
Facility Information:
Facility Name
CHI Creteil
City
Créteil
State/Province
Creteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric SOUIED, MDH
Phone
01 45 17 52 22
Ext
33
Email
eric.souied@chicreteil.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of OMEGA3 Supplementation in Diabetic Retinopathy

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