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

June 18, 2022 updated by: Institut de la Macula y la Retina

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08022
        • Institut de la Macula

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of growth of geographic atrophy (GA) as per SQRT (square roor transformation) of area of GA measured in FAF, (fundus autofluorescence)
Time Frame: 12 months
rate of growth of GA as per SQRT of FAF area compared to rate of growth of the previous year
12 months
safety and tolerability
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de la Macula y la Retina

Collaborators

Igen BioLab SLU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 18, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InstitutMaculaRetina

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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