Dry AMDMADEOSNCT03297515
Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease
A study testing Madeos in people with Dry AMD and Stargardt Disease 1, run by Ophthalmos Research and Education Institute at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dry AMD, Stargardt Disease 1
- What is being tested?
- Madeos
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 15 May 2019to 22 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Italy3 sites
Università degli Studi G. d'Annunzio Chieti-Pescara
Chieti
ASST Santi Paolo e Carlo
Milan
Department of Ophthalmology, University Vita Salute
Milan
Germany1 site
Department of Ophthalmology, Justus-Liebig-University-Giessen
Giessen
About this study
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
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.
Read the 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.
- Conditions
- Dry AMD, Stargardt Disease 1
- Being tested
- Madeos, Placebo
- Keywords
- Omega-3, dry AMD, Stargardt, visual acuity
- Medical subject headings
- Stargardt Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MadeosDietary supplement
Arm 1: Omega 3
PlaceboDietary supplement
Arm 2 : Placebo
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 fatty acids | Experimental | Omega 3 fatty acids Receives: Dietary Supplement: Madeos |
| Placebo | Placebo comparator | Placebo (sunflower oil) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of letters (BCVA) from screening to 24 weeks
Mean change of letters (BCVA) from screening to 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start15 May 2019
- Primary completion22 Sep 2020
- Study completion22 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ophthalmos Research and Education Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297515
- Sponsor's protocol ID
- TG2017
- Acronym
- MADEOS
- Status last verified
- Feb 2021
- First submitted
- 22 Sep 2017
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03297515
- Acronym / sponsor ID
- MADEOS / TG2017
- Conditions
- Dry AMD, Stargardt Disease 1
- Keywords
- Omega-3, dry AMD, Stargardt, visual acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ophthalmos Research and Education InstituteUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega 3 fatty acids | Experimental | Dietary Supplement: MadeosOmega 3 fatty acids |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (sunflower oil) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MadeosArm 1: Omega 3 | Dietary supplement | Omega 3 fatty acids |
| PlaceboArm 2 : Placebo | Dietary supplement | Placebo |
Primary outcome
Mean change of letters (BCVA) from screening to 24 weeks
Time frame: 24 weeks
Mean change of letters (BCVA) from screening to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
Related trials for Dry AMD
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
Not yet recruiting
Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
Cataract, AMD - Age-Related Macular Degeneration
Not yet recruiting
MacuMira Microcurrent Stimulation for Dark Adaptation in Dry Age-Related Macular Degeneration
Age-Related Macular Degeneration (AMD)
Active, not recruitingPhase 1/2
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
Geographic Atrophy
Active, not recruitingPhase 1/2
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
Age-Related Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Madeos in people with Dry AMD and Stargardt Disease 1, run by Ophthalmos Research and Education Institute at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change of letters (BCVA) from screening to 24 weeks (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.