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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03297515
Recruitment Status : Completed
First Posted : September 29, 2017
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Ophthalmos Research and Education Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Dry AMD Stargardt Disease 1 Dietary Supplement: Madeos Dietary Supplement: Placebo Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 15, 2019
Actual Primary Completion Date : September 22, 2020
Actual Study Completion Date : September 22, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Omega 3 fatty acids
Omega 3 fatty acids
 Dietary Supplement: Madeos
Arm 1: Omega 3
Placebo Comparator: Placebo
Placebo (sunflower oil)
 Dietary Supplement: Placebo
Arm 2 : Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Mean change of letters (BCVA) from screening to 24 weeks [ Time Frame: 24 weeks ]
    Mean change of letters (BCVA) from screening to 24 weeks


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 investigational 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:

  • 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.: Steroids, 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 informed consent (impaired mental capacity e.g. psychiatric deficit);
  • Smokers or patients who have not been completely smoke free over the past 5 years.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297515


Locations
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France
Centre National d'Ophtalmologie des Quinze-Vingts
Paris, France
Germany
Department of Ophthalmology, Justus-Liebig-University-Giessen
Gießen, Germany
Italy
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
Sponsors and Collaborators
Ophthalmos Research and Education Institute
More Information
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Responsible Party: Ophthalmos Research and Education Institute
ClinicalTrials.gov Identifier: NCT03297515    
Other Study ID Numbers: TG2017
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ophthalmos Research and Education Institute:
Omega-3
dry AMD
Stargardt
visual acuity
Additional relevant MeSH terms:
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Macular Degeneration
Stargardt Disease
Geographic Atrophy
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn