Oral Postbiotics in Patients With Macular Atrophy

Age-Related Macular Degeneration Clinical Trial

— REVERS-GA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05391074
• Other study ID #: InstitutMaculaRetina
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2022
• Source: Institut de la Macula y la Retina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: June 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Dietary Supplement:
• postbiotics (IGENH35.3A)
postbiotics to induce microbiota epigenetic factors
• vitamins (AREDS formulation and recommended daily dose)
vitamins (AREDS to prevent AMD progression

Locations

Country	Name	City	State
Spain	Institut de la Màcula	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Institut de la Macula y la Retina	Igen BioLab SLU

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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