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CompletedNCT03297515MADEOSUpdated Feb 23, 2021

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

An interventional study of Madeos and Placebo in Dry AMD and Stargardt Disease 1, sponsored by Ophthalmos Research and Education Institute. Completed at 5 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-02-23.

Sponsored by Ophthalmos Research and Education Institute · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dry AMD
  • Stargardt Disease 1

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Keywords

  • Omega-3
  • dry AMD
  • Stargardt
  • visual acuity
03

In context

Stargardt Disease

66 studies on the registry are indexed under Stargardt Disease; 25 are open to participants now.

This study's enrollment of 32 is close to the median of 30 across 43 interventional studies indexed under Stargardt Disease.

Browse Stargardt Disease studies →

Lead sponsor

This is the only study on the registry with Ophthalmos Research and Education Institute as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women ages from 18 to 85 years old.
  • Group 1: For moderate dry macular degeneration the BCVA must be between 50 and 70 (ETDRS) at Screening Visit V1. There must be a large drusen >125 µm within 1mm from the centre of the fovea. Geographic atrophy can be present but must be >300 µm away from centre of fovea;
  • Group 2: For severe dry macular degeneration the BCVA must be between 41 and 49 (ETDRS) at Screening Visit V1. Geographic atrophy can involve the fovea but must be \<2500 µm in diameter or any size GA but >200 µm from centre of fovea anywhere;
  • Group 3: For moderate Stargardt disease the BCVA must be between 50 and 70 (ETDRS) at Screening Visit V1. The geographic area must be \<2.0 mm in diameter anywhere;
  • Group 4: For severe Stargardt disease the BCVA must be between 41 and 49 (ETDRS) at Screening Visit V1. The geographic area must be \<2.5 mm in diameter anywhere;
  • Willingness to take the randomised trial product for 6 months;
  • Willingness to consent and undergo the examinations/blood testing at the visits;
  • Be able to swallow large soft gel capsules;
  • Take other supplements as usual; The EPA and DHA intake must be less than 1200 mg/day.

Exclusion criteria

Exclusion Criteria:

  • Any ocular disease in either eye including: Diabetic retinopathy, Central serous retinopathy, Epiretinal membrane, Optic atrophy, Macular hole or pseudohole, Retinal vein occlusion, Amblyopia;
  • Previous wet AMD in the study eye;
  • Any previous ocular surgery, which may influence progression of dry macular degeneration e.g. trabeculectomy, previous refractive surgery, pterygium surgery. Cataract surgery more than 6 months is not an exclusion criterion unless a complication has occurred during surgery;
  • Any topical medication administered for other diseases such as glaucoma. Artificial tears up to 3/day will be allowed;
  • Any ocular condition such as allergic conjunctivitis, moderate to severe dry eyes, scleritis, uveitis, keratitis, ocular Herpes Simplex keratitis, ectropion, entropion, ocular surface scaring;
  • Any systemic conditions such as gastrointestinal disease e.g. irritable bowel syndrome, Crohn's disease, cancer, etc;
  • Any drugs which could affect the eye administered up to 6 months before screening e.g.: , Ethambutol, Tamoxifen, Chloroquine, Hydroxychloroquine;
  • Any condition that would not allow follow up e.g. alcoholism or drug abuse;
  • Allergy to any ingredients of the active or placebo pills.
  • Pregnant or lactating;
  • Current use of EPA/DHA supplements in excess of 1200 mg/day;
  • History of liver disease;
  • Anti-coagulation therapy such as warfarin/heparin/aspirin/dabigatran/ clopidogrel etc;
  • Bleeding tendencies e.g. coagulopathies;
  • History of atrial fibrillation;
  • Inability to give (impaired mental capacity e.g. psychiatric deficit);
  • Smokers or patients who have not been completely smoke free over the past 5 years.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Omega 3 fatty acids

    Omega 3 fatty acids

    Dietary Supplement: Madeos

  • Placebo comparator
    Placebo

    Placebo (sunflower oil)

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementMadeos

    Arm 1: Omega 3

  • Dietary supplementPlacebo

    Arm 2 : Placebo

06

What researchers measure

Primary outcomes

  1. Mean change of letters (BCVA) from screening to 24 weeks

    Mean change of letters (BCVA) from screening to 24 weeks

    Time frame: 24 weeks

07

Study locations

5 sites
  • Centre National d'Ophtalmologie des Quinze-Vingts
    Paris, France
  • Department of Ophthalmology, Justus-Liebig-University-Giessen
    Gießen, Germany
  • Università degli Studi G. d'Annunzio Chieti-Pescara
    Chieti, Italy
  • ASST Santi Paolo e Carlo
    Milan, Italy
  • Department of Ophthalmology, University Vita Salute
    Milan, Italy
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2019 to primary completion in Sep 2020, 16 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2017
First posted
Sep 29, 2017
StartActual
May 15, 2019
Primary completionActual
Sep 22, 2020
CompletionActual
Sep 22, 2020
Last update
Feb 23, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03297515
Lead sponsor
Ophthalmos Research and Education Institute
Responsible party
Sponsor
First posted
Sep 29, 2017
Start date
May 15, 2019
Primary completion
Sep 22, 2020
Completion
Sep 22, 2020
Last update
Feb 23, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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