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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 March 2021
• Main ID: NCT03297515
• Date of registration: 22/09/2017
• Prospective Registration: Yes
• Primary sponsor: Ophthalmos Research and Education Institute
• Public title: Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease MADEOS
• Scientific 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
• Date of first enrolment: May 15, 2019
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03297515
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

France, Germany, Italy

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dry AMD

Stargardt Disease 1

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Madeos

Primary Outcome(s)

Mean change of letters (BCVA) from screening to 24 weeks [Time Frame: 24 weeks]

Secondary ID(s)

TG2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors