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Trial record 13 of 32 for:    stargardt

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

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ClinicalTrials.gov Identifier: NCT03297515
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ophthalmos Research and Education Institute

Tracking Information
First Submitted Date  ICMJE September 22, 2017
First Posted Date  ICMJE September 29, 2017
Last Update Posted Date November 6, 2019
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date March 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2017)
Mean change of letters (BCVA) from screening to 24 weeks [ Time Frame: 24 weeks ]
Mean change of letters (BCVA) from screening to 24 weeks
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2017)
Mean change of letters (BCVA) from baseline to 24 weeks [ Time Frame: 24 weeks ]
Mean change of letters (BCVA) from baseline to 24 weeks
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Dry AMD
  • Stargardt Disease 1
Intervention  ICMJE
  • Dietary Supplement: Madeos
    Arm 1: Omega 3
  • Dietary Supplement: Placebo
    Arm 2 : Placebo
Study Arms  ICMJE
  • Experimental: Omega 3 fatty acids
    Omega 3 fatty acids
    Intervention: Dietary Supplement: Madeos
  • Placebo Comparator: Placebo
    Placebo (sunflower oil)
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date March 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tassos Georgiou, MD +357 224 643 44 tassosgeorgiou@hotmail.com
Listed Location Countries  ICMJE France,   Germany,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03297515
Other Study ID Numbers  ICMJE TG2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ophthalmos Research and Education Institute
Study Sponsor  ICMJE Ophthalmos Research and Education Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ophthalmos Research and Education Institute
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP