Oral Postbiotics in Patients With Macular Atrophy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Geographic Atrophy, Age-Related Macular Degeneration

Intervention / Treatment
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* Dietary Supplement: postbiotics (IGENH35.3A)
* Dietary Supplement: vitamins (AREDS formulation and recommended daily dose)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with GA secondary to AMD, myopia or angioid streaks<br>postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose) | Dietary Supplement: postbiotics (IGENH35.3A)<br>* postbiotics to induce microbiota epigenetic factors<br>Dietary Supplement: vitamins (AREDS formulation and recommended daily dose)<br>* vitamins (AREDS to prevent AMD progression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of growth of geographic atrophy (GA) as per SQRT (square roor transformation) of area of GA measured in FAF, (fundus autofluorescence) | rate of growth of GA as per SQRT of FAF area compared to rate of growth of the previous year | 12 months | 
| safety and tolerability | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postbiotics, microbiota, microbiome, geographic atrophy, atrophic AMD, AMD, age-related macular degeneration