Oral Postbiotics in Patients With Macular Atrophy

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05391074

Acronym

REVERS-GA

Enrollment

Registered

2022-05-25

Start date

2020-12-01

Completion date

2024-06-01

Last updated

2022-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration, Geographic Atrophy

Keywords

postbiotics, microbiota, microbiome, geographic atrophy, atrophic AMD, AMD, age-related macular degeneration

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.

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.

Interventions

DIETARY_SUPPLEMENTpostbiotics (IGENH35.3A)

postbiotics to induce microbiota epigenetic factors

DIETARY_SUPPLEMENTvitamins (AREDS formulation and recommended daily dose)

vitamins (AREDS to prevent AMD progression

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026