Oral Postbiotics in Patients With Macular Atrophy
REVERS-GA
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
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 20, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedJune 24, 2022
June 1, 2022
3 years
May 20, 2022
June 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
12 months
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
12 months
Study Arms (1)
patients with GA secondary to AMD, myopia or angioid streaks
EXPERIMENTALpostbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)
Interventions
postbiotics to induce microbiota epigenetic factors
vitamins (AREDS to prevent AMD progression
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- history of choroidal neovascularization in the study eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut de la Macula y la Retinalead
- Igen BioLab SLUcollaborator
Study Sites (1)
Institut de la Màcula
Barcelona, 08022, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jordi Monés, MD, PhD
Institut de la Màcula
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2022
First Posted
May 25, 2022
Study Start
December 1, 2020
Primary Completion
December 1, 2023
Study Completion
June 1, 2024
Last Updated
June 24, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share