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

Institut de la Macula y la Retina

Status: Active, not recruiting

Conditions: Age-Related Macular Degeneration; Geographic Atrophy

Treatments: Dietary Supplement: postbiotics (IGENH35.3A); Dietary Supplement: vitamins (AREDS formulation and recommended daily dose)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05391074

InstitutMaculaRetina

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 55 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

patients with GA secondary to AMD, myopia or angioid streaks

Experimental group

Description:

postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)

Treatment:

Dietary Supplement: postbiotics (IGENH35.3A)

Dietary Supplement: vitamins (AREDS formulation and recommended daily dose)