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Oral Postbiotics in Patients With Macular Atrophy (REVERS-GA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05391074
Recruitment Status : Active, not recruiting
First Posted : May 25, 2022
Last Update Posted : June 24, 2022
Sponsor:
Collaborator:
Igen BioLab SLU
Information provided by (Responsible Party):
Institut de la Macula y la Retina

Study Description
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Brief Summary:
A pilot study to evaluate the safety and efficacy of oral therapy with Postbiotics in patients with geographic atrophy secondary to age-related macular degeneration, myopia, or angioid streaks.

Condition or disease Intervention/treatment Phase
Geographic Atrophy Age-Related Macular Degeneration Dietary Supplement: postbiotics (IGENH35.3A) Dietary Supplement: vitamins (AREDS formulation and recommended daily dose) Not Applicable

Detailed Description:

A pilot study to evaluate the safety and efficacy of oral therapy with Postbiotics in patients with geographic atrophy (GA) secondary to age-related macular degeneration, myopia or angioid streaks.

The study's main objective is to evaluate if oral postbiotic therapy will induce epigenetic factors that would impact the progression of the GA, and it will compare the rate of growth of GA from the Baseline to 12 months, to the rate shown during the 12 months before Baseline.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate the Safety and Efficacy of Oral Therapy With Postbiotics in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration, Myopia, or Angioid Streaks
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: patients with GA secondary to AMD, myopia or angioid streaks
postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)
 Dietary Supplement: postbiotics (IGENH35.3A)
postbiotics to induce microbiota epigenetic factors

Dietary Supplement: vitamins (AREDS formulation and recommended daily dose)
vitamins (AREDS to prevent AMD progression


Outcome Measures
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Primary Outcome Measures :
  1. rate of growth of geographic atrophy (GA) as per SQRT (square roor transformation) of area of GA measured in FAF, (fundus autofluorescence) [ Time Frame: 12 months ]
    rate of growth of GA as per SQRT of FAF area compared to rate of growth of the previous year

  2. safety and tolerability [ Time Frame: 12 months ]
    safety and tolerability of daily dosing of oral postbiotics assessed by number of patients with clinically significant changes of a combination of ocular and/or non-ocular adverse events


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with GA secondary to AMD, myopia or angioid streaks
  • with 12 months of previous follow-up,
  • and a known progression of >0,20mm/year as per SQRT

Exclusion Criteria:

- history of choroidal neovascularization in the study eye

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05391074


Locations
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Spain
Institut de la Màcula
Barcelona, Spain, 08022
Sponsors and Collaborators
Institut de la Macula y la Retina
Igen BioLab SLU
Investigators
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Principal Investigator: Jordi Monés, MD, PhD Institut de la Màcula
More Information
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Responsible Party: Institut de la Macula y la Retina
ClinicalTrials.gov Identifier: NCT05391074    
Other Study ID Numbers: InstitutMaculaRetina
First Posted: May 25, 2022    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de la Macula y la Retina:
postbiotics
microbiota
microbiome
geographic atrophy
 atrophic AMD
AMD
age-related macular degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Pathological Conditions, Anatomical
Vitamins
Micronutrients
Physiological Effects of Drugs