Oral Postbiotics in Patients With Macular Atrophy

Not Applicable

• Conditions: Geographic Atrophy; Age-Related Macular Degeneration
• Interventions: Dietary Supplement: postbiotics (IGENH35.3A); Dietary Supplement: vitamins (AREDS formulation and recommended daily dose)

• Registration Number: NCT05391074
• Lead Sponsor: Institut de la Macula y la Retina

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.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-25
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-18
• Last Update Posted: 2022-06-24
• Primary Completion: 2023-12-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with GA secondary to AMD, myopia or angioid streaks	postbiotics (IGENH35.3A)	postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)
patients with GA secondary to AMD, myopia or angioid streaks	vitamins (AREDS formulation and recommended daily dose)	postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut de la Màcula; 🇪🇸 Barcelona, Spain