NCT05391074

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Institut de la Macula y la Retina · Academic / Other
• Sex: All
• Age: 55 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Geographic Atrophy
• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	postbiotics (IGENH35.3A)	postbiotics to induce microbiota epigenetic factors
DIETARY_SUPPLEMENT	vitamins (AREDS formulation and recommended daily dose)	vitamins (AREDS to prevent AMD progression

Timeline

• Start date: 2020-12-01
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2022-05-25
• Last updated: 2022-06-24

Locations

1 site across 1 country: Spain