NCT03297515

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2020

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

September 22, 2017

Last Update Submit

February 22, 2021

Conditions

Dry AMDStargardt Disease 1

Keywords

Omega-3dry AMDStargardtvisual acuity

Outcome Measures

Primary Outcomes (1)

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

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

    24 weeks

Study Arms (2)

Omega 3 fatty acids

EXPERIMENTAL

Omega 3 fatty acids

Dietary Supplement: Madeos

Placebo

PLACEBO COMPARATOR

Placebo (sunflower oil)

Dietary Supplement: Placebo

Interventions

MadeosDIETARY_SUPPLEMENT

Arm 1: Omega 3

Omega 3 fatty acids
PlaceboDIETARY_SUPPLEMENT

Arm 2 : Placebo

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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);
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre National d'Ophtalmologie des Quinze-Vingts

Paris, France

Location

Department of Ophthalmology, Justus-Liebig-University-Giessen

Giessen, Germany

Location

Università degli Studi G. d'Annunzio Chieti-Pescara

Chieti, Italy

Location

ASST Santi Paolo e Carlo

Milan, Italy

Location

Department of Ophthalmology, University Vita Salute

Milan, Italy

Location

MeSH Terms

Conditions

Stargardt Disease

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesMacular DegenerationRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2017

First Posted

September 29, 2017

Study Start

May 15, 2019

Primary Completion

September 22, 2020

Study Completion

September 22, 2020

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

IT(3)DE(1)FR(1)