REVERS-GA: Oral Postbiotics in Patients With Macular Atrophy

• Sponsor: Institut de la Macula y la Retina (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05391074
• Collaborator: Igen BioLab SLU (Industry)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 42
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Geographic Atrophy; Age-Related Macular Degeneration	Dietary Supplement: postbiotics (IGENH35.3A); Dietary Supplement: vitamins (AREDS formulation and recommended daily dose)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patients with GA secondary to AMD, myopia or angioid streaks postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)	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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de la Màcula	Barcelona		Spain	08022

Sponsors and Collaborators

• Institut de la Macula y la Retina
• Igen BioLab SLU

Investigators

• Principal Investigator: Jordi Monés, MD, PhD, Institut de la Màcula

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut de la Macula y la Retina
• ClinicalTrials.gov Identifier: NCT05391074
• Other Study ID Numbers: InstitutMaculaRetina
• First Posted: May 25, 2022
• Last Update Posted: Jun 24, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Institut de la Macula y la Retina: postbiotics; microbiota; microbiome; geographic atrophy; atrophic AMD; AMD; age-related macular degeneration
• Additional relevant MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy; Vitamins

Study Results

No Results Posted as of Jun 24, 2022