AMDREVERSNCT05056025
Study to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration.
A study testing Postbotics and Vitamins and Vitamins in people with AMD and Soft Drusen, run by Institut de la Macula y la Retina at 1 site in Spain.
Trial summary
A pilot study to establish the efficacy and safety of supplementation with postbiotics in patients with macular degeneration. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- AMD, Soft Drusen, Reticular Pseudodrusen
- What is being tested?
- Postbotics and Vitamins and Vitamins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 2 Dec 2020to Jan 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of either gender aged 50 years or older with high risk intermediate AMD defined as the following criteria:
- >4 areas of at least iRORA or iORA (incomplete RPE and outer retinal atrophy and incomplete outer retinal atrophy).
- 1 area of cRORA + 2 > areas of iRORA. < 1 mm2 of cRORA (complete RPE and outer retinal atrophy). No exudative neovascular AMD.
Who cannot join
- Best corrected visual acuity in the study eye less than 20/400 by ETDRS. Not ability to provide written informed consent. Not ability to return for all trial visits. if subject cannot attend all trial required visits. GA secondary to any condition other than specified. Any ocular condition in the study eye that would progress during the study that could affect central vision or otherwise be a confounding factor.
- Concomitant treatment with any ocular or systemic medication that is known to be toxic to the lens, retina or optic nerve. Anti -VEGF therapy is allowed in Cohort B.
- Presence of intraocular inflammation (≥ trace cell or flare), macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreo-retinal traction maculopathy, vitreous hemorrhage or aphakia (pseudophakia with or without an intact capsule is not an exclusion criteria).
- Presence of idiopathic or autoimmune-associated uveitis in either eye. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, fundus photography or fundus autofluorescence. Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the following year.
- Any intraocular surgery or thermal laser within three (3) months of trial entry.
- Any prior thermal laser in the macular region, regardless of indication. History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant or retinal detachment.
- Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition.
- Pregnant or nursing women. Additionally, women with childbearing potential must be using at least two effective contraception methods.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Institut de la Macula
Barcelona, 08022
Jordi M Mones, MD, PhD, +34935950155, jmones@institutmacula.com
Marc Biarnes, OD, PhD, +34935950155, mbiarnes@institutmacula.com
About this study
Official title: A PILOT STUDY TO EVALUATE THE PROGRESSION OF THE DISEASE AND RESPONSE TO SUPPLEMENTATION WITH POSTBIOTICS IGEN-0222 IN PATIENTS WITH MACULAR DEGENERATION
A pilot study to establish the efficacy and safety of supplementation with postbiotics in patients with macular degeneration.
- Conditions
- AMD, Soft Drusen, Reticular Pseudodrusen, Drusen Stage Macular Degeneration, Drusen (Degenerative) of Macula, Bilateral
- Being tested
- Postbotics and Vitamins, Vitamins
- Keywords
- postbiotic, vitamins, drusen, intermediate AMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postbotics and VitaminsDietary supplement
2 capsule 3 times a day, before meals
VitaminsDietary supplement
2 capsule 3 times a day, before meals
| Study group | Role | What they receive |
|---|---|---|
| postbiotics with vitamins | Experimental | postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose) Receives: Dietary Supplement: Postbotics and Vitamins |
| vitamins | Placebo comparator | vitamins (AREDS formulation and recommended daily dose) Receives: Dietary Supplement: Vitamins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microperimetry
Median change difference in the % reduced threshold in microperimetry
Measured: 12 months
Color vision change
Median change in red/green and yellow/blue color thresholds
Measured: 12 months
Secondary outcomes (14)
Average Threshold microperimetry
Mean change of Average Threshold microperimetry
Measured: 12 months
Best corrected visual acuity (BCVA)
Mean Change of Best corrected visual acuity (BCVA)
Measured: 12 months
Low luminance visual acuity (LLVA)
Mean Change of Low luminance visual acuity (LLVA)
Measured: 12 months
Rod and cone sensitivity
Mean change of Rod and cone sensitivity test
Measured: 12 months
Advanced Vision and Optometric Test (AVOT)
Mean change AVOT vision test
Measured: 12 months
incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) conversion loci
Number of scans within the optical coherence tomography OCT cube as as per protocol (Spectralis OCT cube protocol: 20º x 20ª, 97b-scan, high-resolution, 62 microns between scans centered at the fovea) with features of iRORA2 conversion loci (change from baseline to 12 months of iRORA loci).
Measured: 12 months
complete retinal pigment epithelial and outer retinal atrophy (cRORA) conversion loci
Number of scans within the OCT cube as as per protocol with of features of cRORA (change from baseline to 12 months of cRORA loci).
Measured: 12 months
Area of cumulative cRORA conversion
Area of cumulative cRORA conversion as measured in mm2 by en face OCT projection scans of the OCT cube as as per protocol
Measured: 12 months
Hyperreflective dots(HRD)+ (retinal pigment epithelium)RPE defects areas conversion
Number of scans within the OCT cube as as per protocol with HRD+RPE defects areas conversion (change from baseline to 12 months of HRD+RPE defects)
Measured: 12 months
Change in outer nuclear layer (ONL) volume
Change in outer nuclear layer (ONL) volume measured by the spectralis software after manually correction of the layer segmentation
Measured: 12 months
Change of drusen > 100 microns height
Change of number of drusen of > 100 microns height measured by OCT within the OCT cube as as per protocol
Measured: 12 months
Change of subretinal drusenoid deposits (SDD) through ellipsoid zone (ELZ)
Change of number of subretinal drusenoid deposits (SDD) through ellipsoid zone within the OCT cube as as per protocol
Measured: 12 months
Change of SDD ribbon
Change of number SDD ribbon within the OCT cube as as per protocol
Measured: 12 months
Conversion to choroidal neovascularization (CNV)
Any conversion to any type of macular neovascularization (MNV) within the OCT cube as as per protocol 1 as per OCT features of leakage, and/or intrarretinal, subretinal or subRPE fluid, and/or presence of Subretinal hyperreflective material(SHRM)
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 posted24 Sep 2021
- Study start2 Dec 2020
- Primary completionJan 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMDStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 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
- Principal investigator, Jordi Mones MD PhD, Institut de la Macula y la Retina
- Investigators
- Jordi Mones, MD, PhD, Principal investigator, Institut de la Macula
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056025
- Sponsor's protocol ID
- 2020/79-MIN-HUGC
- Acronym
- REVERS
- Status last verified
- Sep 2021
- First submitted
- 15 Apr 2021
- Last updated
- 24 Sep 2021
- 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 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PILOT STUDY TO EVALUATE THE PROGRESSION OF THE DISEASE AND RESPONSE TO SUPPLEMENTATION WITH POSTBIOTICS IGEN-0222 IN PATIENTS WITH MACULAR DEGENERATION
- ClinicalTrials.gov ID
- NCT05056025
- Acronym / sponsor ID
- REVERS / 2020/79-MIN-HUGC
- Conditions
- AMD, Soft Drusen, Reticular Pseudodrusen, Drusen Stage Macular Degeneration, Drusen (Degenerative) of Macula, Bilateral
- Keywords
- postbiotic, vitamins, drusen, intermediate AMD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Institut de la Macula y la RetinaUniversity, hospital or other
- Collaborators
- Igen BioLab SLU
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 24 Sep 2021 (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 establish the efficacy and safety of supplementation with postbiotics in patients with macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postbiotics with vitamins | Experimental | Dietary Supplement: Postbotics and Vitaminspostbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose) |
| vitamins | Placebo comparator | Dietary Supplement: Vitaminsvitamins (AREDS formulation and recommended daily dose) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects of either gender aged 50 years or older with high risk intermediate AMD defined as the following criteria:
- >4 areas of at least iRORA or iORA (incomplete RPE and outer retinal atrophy and incomplete outer retinal atrophy).
- 1 area of cRORA + 2 > areas of iRORA. < 1 mm2 of cRORA (complete RPE and outer retinal atrophy). No exudative neovascular AMD.
Key exclusion criteria (8 listed)
- Best corrected visual acuity in the study eye less than 20/400 by ETDRS. Not ability to provide written informed consent. Not ability to return for all trial visits. if subject cannot attend all trial required visits. GA secondary to any condition other than specified. Any ocular condition in the study eye that would progress during the study that could affect central vision or otherwise be a confounding factor.
- Concomitant treatment with any ocular or systemic medication that is known to be toxic to the lens, retina or optic nerve. Anti -VEGF therapy is allowed in Cohort B.
- Presence of intraocular inflammation (≥ trace cell or flare), macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreo-retinal traction maculopathy, vitreous hemorrhage or aphakia (pseudophakia with or without an intact capsule is not an exclusion criteria).
- Presence of idiopathic or autoimmune-associated uveitis in either eye. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, fundus photography or fundus autofluorescence. Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the following year.
- Any intraocular surgery or thermal laser within three (3) months of trial entry.
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 |
|---|---|---|
| Postbotics and Vitamins2 capsule 3 times a day, before meals | Dietary supplement | postbiotics with vitamins |
| Vitamins2 capsule 3 times a day, before meals | Dietary supplement | vitamins |
Primary outcome
Microperimetry
Time frame: 12 months
Median change difference in the % reduced threshold in microperimetry
Color vision change
Time frame: 12 months
Median change in red/green and yellow/blue color thresholds
14 secondary outcomes
Average Threshold microperimetry
Time frame: 12 months
Best corrected visual acuity (BCVA)
Time frame: 12 months
Low luminance visual acuity (LLVA)
Time frame: 12 months
Rod and cone sensitivity
Time frame: 12 months
Advanced Vision and Optometric Test (AVOT)
Time frame: 12 months
incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) conversion loci
Time frame: 12 months
complete retinal pigment epithelial and outer retinal atrophy (cRORA) conversion loci
Time frame: 12 months
Area of cumulative cRORA conversion
Time frame: 12 months
Hyperreflective dots(HRD)+ (retinal pigment epithelium)RPE defects areas conversion
Time frame: 12 months
Change in outer nuclear layer (ONL) volume
Time frame: 12 months
Change of drusen > 100 microns height
Time frame: 12 months
Change of subretinal drusenoid deposits (SDD) through ellipsoid zone (ELZ)
Time frame: 12 months
Change of SDD ribbon
Time frame: 12 months
Conversion to choroidal neovascularization (CNV)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Individual participant dataSharing planned: No
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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 Mones, MD, PhD principal investigator
Institut de la Macula
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postbotics and Vitamins and Vitamins in people with AMD and Soft Drusen, 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 8 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 Sep 2021. 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. Some participants in this study may receive a placebo. 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?
Contact Jordi Mones, MD PhD (+34 935 950 155, jmones@institutmacula.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microperimetry (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 Sep 2021.