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

Primary Purpose

Geographic Atrophy, Age-Related Macular Degeneration

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
postbiotics (IGENH35.3A)
vitamins (AREDS formulation and recommended daily dose)
Sponsored by
Institut de la Macula y la Retina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy focused on measuring postbiotics, microbiota, microbiome, geographic atrophy, atrophic AMD, AMD, age-related macular degeneration

Eligibility Criteria

55 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institut de la Màcula

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with GA secondary to AMD, myopia or angioid streaks

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
May 20, 2022
Last Updated
June 18, 2022
Sponsor
Institut de la Macula y la Retina
Collaborators
Igen BioLab SLU
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1. Study Identification

Unique Protocol Identification Number
NCT05391074
Brief Title
Oral Postbiotics in Patients With Macular Atrophy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de la Macula y la Retina
Collaborators
Igen BioLab SLU

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy, Age-Related Macular Degeneration
Keywords
postbiotics, microbiota, microbiome, geographic atrophy, atrophic AMD, AMD, age-related macular degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with GA secondary to AMD, myopia or angioid streaks
Arm Type
Experimental
Arm Description
postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)
Intervention Type
Dietary Supplement
Intervention Name(s)
postbiotics (IGENH35.3A)
Intervention Description
postbiotics to induce microbiota epigenetic factors
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamins (AREDS formulation and recommended daily dose)
Intervention Description
vitamins (AREDS to prevent AMD progression
Primary Outcome Measure Information:
Title
rate of growth of geographic atrophy (GA) as per SQRT (square roor transformation) of area of GA measured in FAF, (fundus autofluorescence)
Description
rate of growth of GA as per SQRT of FAF area compared to rate of growth of the previous year
Time Frame
12 months
Title
safety and tolerability
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordi Monés, MD, PhD
Organizational Affiliation
Institut de la Màcula
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de la Màcula
City
Barcelona
ZIP/Postal Code
08022
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Oral Postbiotics in Patients With Macular Atrophy

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