Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT04499820
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2020-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of OMEGA3 Supplementation in Diabetic Retinopathy
Sponsor:
Centre Hospitalier Intercommunal Creteil
Organization:
Study Overview
Official Title:
Effet d'Une supplémentation Par OMEGA3 Dans la rétinopathie diabétique
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OMEDIA
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: