Geographic AtrophyREVERS-GANCT05391074
Oral Postbiotics in Patients With Macular Atrophy
A study testing postbiotics (IGENH35.3A) and vitamins (AREDS formulation and recommended daily dose) in people with Geographic Atrophy and Age-Related Macular Degeneration, run by Institut de la Macula y la Retina at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 100 years
- Conditions the study is for
- Geographic Atrophy, Age-Related Macular Degeneration
- What is being tested?
- postbiotics (IGENH35.3A) and vitamins (AREDS formulation and recommended daily dose)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2020to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- history of choroidal neovascularization in the study eye
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- postbiotics (IGENH35.3A), vitamins (AREDS formulation and recommended daily dose)
- Keywords
- postbiotics, microbiota, microbiome, geographic atrophy, atrophic AMD, AMD, age-related macular degeneration
- Medical subject headings
- Geographic Atrophy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postbiotics (IGENH35.3A)Dietary supplement
postbiotics to induce microbiota epigenetic factors
vitamins (AREDS formulation and recommended daily dose)Dietary supplement
vitamins (AREDS to prevent AMD progression
| Study group | Role | What they receive |
|---|---|---|
| patients with GA secondary to AMD, myopia or angioid streaks | Experimental | postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose) Receives: Dietary Supplement: postbiotics (IGENH35.3A); Dietary Supplement: vitamins (AREDS formulation and recommended daily dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Dec 2020
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de la Macula y la Retina
- Sponsor type
- University, hospital or other
- Collaborators
- Igen BioLab SLU
- Responsible party
- Sponsor
- Investigators
- Jordi Monés, MD, PhD, Principal investigator, Institut de la Màcula
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391074
- Sponsor's protocol ID
- InstitutMaculaRetina
- Acronym
- REVERS-GA
- Status last verified
- Jun 2022
- First submitted
- 20 May 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05391074
- Acronym / sponsor ID
- REVERS-GA / InstitutMaculaRetina
- Keywords
- postbiotics, microbiota, microbiome, geographic atrophy, atrophic AMD, AMD, age-related macular degeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institut de la Macula y la RetinaUniversity, hospital or other
- Collaborators
- Igen BioLab SLU
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with GA secondary to AMD, myopia or angioid streaks | Experimental | Dietary Supplement: postbiotics (IGENH35.3A), Dietary Supplement: vitamins (AREDS formulation and recommended daily dose)postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose) |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- history of choroidal neovascularization in the study eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postbiotics (IGENH35.3A)postbiotics to induce microbiota epigenetic factors | Dietary supplement | patients with GA secondary to AMD, myopia or angioid streaks |
| vitamins (AREDS formulation and recommended daily dose)vitamins (AREDS to prevent AMD progression | Dietary supplement | patients with GA secondary to AMD, myopia or angioid streaks |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Geographic Atrophy
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
Geographic Atrophy, Stargardt Disease
RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordi Monés, MD, PhD principal investigator
Institut de la Màcula
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postbiotics (IGENH35.3A) and vitamins (AREDS formulation and recommended daily dose) in people with Geographic Atrophy and Age-Related Macular Degeneration, run by Institut de la Macula y la Retina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.