Study to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration.
NCT ID: NCT05056025
Last Updated: 2021-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
48 participants
INTERVENTIONAL
2020-12-02
2024-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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postbiotics with vitamins
postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)
Postbotics and Vitamins
2 capsule 3 times a day, before meals
vitamins
vitamins (AREDS formulation and recommended daily dose)
Vitamins
2 capsule 3 times a day, before meals
Interventions
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Postbotics and Vitamins
2 capsule 3 times a day, before meals
Vitamins
2 capsule 3 times a day, before meals
Eligibility Criteria
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Inclusion Criteria
\>4 areas of at least iRORA or iORA (incomplete RPE and outer retinal atrophy and incomplete outer retinal atrophy).
1 area of cRORA + 2 \> areas of iRORA. \< 1 mm2 of cRORA (complete RPE and outer retinal atrophy). No exudative neovascular AMD.
Exclusion Criteria
Concomitant treatment with any ocular or systemic medication that is known to be toxic to the lens, retina or optic nerve. Anti -VEGF therapy is allowed in Cohort B.
Presence of idiopathic or autoimmune-associated uveitis in either eye. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, fundus photography or fundus autofluorescence. Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the following year.
Any intraocular surgery or thermal laser within three (3) months of trial entry.
Any prior thermal laser in the macular region, regardless of indication. History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant or retinal detachment.
Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition.
Pregnant or nursing women. Additionally, women with childbearing potential must be using at least two effective contraception methods.
50 Years
ALL
No
Sponsors
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Igen BioLab SLU
INDUSTRY
Institut de la Macula y la Retina
OTHER
Responsible Party
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Jordi Mones MD PhD
Jordi Mones MD, PhD
Principal Investigators
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Jordi Mones, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut de la Macula
Locations
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Institut de la Macula
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020/79-MIN-HUGC
Identifier Type: -
Identifier Source: org_study_id
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