Study to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration.

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    48
  • sponsor
    Institut de la Macula y la Retina
Updated on 1 October 2021
atrophy
vitamin
macular degeneration

Summary

A pilot study to establish the efficacy and safety of supplementation with postbiotics in patients with macular degeneration.

Details
Condition Methyldopa, Reticular Pseudodrusen, alpha-methyldopa, Macular Degeneration, Soft Drusen, age-related macular degeneration, Glycogen storage disease type II, Drusen (Degenerative) of Macula, Bilateral, Pompe Disease, Drusen Stage Macular Degeneration
Treatment Vitamins, Postbotics and Vitamins
Clinical Study IdentifierNCT05056025
SponsorInstitut de la Macula y la Retina
Last Modified on1 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects of either gender aged 50 years or older with high risk intermediate AMD defined as the following criteria
>4 areas of at least iRORA or iORA (incomplete RPE and outer retinal atrophy
and incomplete outer retinal atrophy)
area of cRORA + 2 > areas of iRORA. < 1 mm2 of cRORA (complete RPE and outer
retinal atrophy). No exudative neovascular AMD

Exclusion Criteria

Best corrected visual acuity in the study eye less than 20/400 by ETDRS. Not
ability to provide written informed consent. Not ability to return for all
trial visits. if subject cannot attend all trial required visits. GA secondary
to any condition other than specified. Any ocular condition in the study eye
that would progress during the study that could affect central vision or
otherwise be a confounding factor
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 intraocular inflammation ( trace cell or flare), macular hole
pathologic myopia, epiretinal membrane, evidence of significant vitreo-retinal
traction maculopathy, vitreous hemorrhage or aphakia (pseudophakia with or
without an intact capsule is not an exclusion criteria)
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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