| Eligibility |
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.
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