NCT03297515

Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease

Prospective, Randomised, Double-blind Study to Assess the Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease (Macular Degeneration Omega-3 Study - MADEOS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ophthalmos Research and Education Institute · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Prospective, randomised, double-blind study to assess the Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease (Macular Degeneration Omega-3 Study - MADEOS.

Detailed description

Age-related macular degeneration (AMD) is the leading cause of blindness in developed countries. By the year 2040, the number of people suffering from AMD is estimated to increase by 50%. Stargardt disease is the most prevalent form of macular dystrophy in children, with an estimated prevalence of 1 in 10000. There is no effective treatment available that stops progression or improves vision in patients with dry AMD or Stargardt disease. Considering the success in animal studies and observational human studies with omega-3 fatty acids supplementation when the blood ratio AA (arachidonic acid)/EPA (eicosapentaenoic acid) is \<2, the sponsor hypothesizes that, when the blood ratio of AA/EPA is maintained below 2, the visual acuity in the group with active supplements will improve, in comparison to the control group, in patients with moderate and severe dry AMD and moderate and severe Stargardt.

Conditions

• Dry AMD
• Stargardt Disease 1

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Madeos	Arm 1: Omega 3
DIETARY_SUPPLEMENT	Placebo	Arm 2 : Placebo

Timeline

• Start date: 2019-05-15
• Primary completion: 2020-09-22
• Completion: 2020-09-22
• First posted: 2017-09-29
• Last updated: 2021-02-23

Locations

5 sites across 3 countries: France, Germany, Italy