Back to resultsStudy to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration. (REVERS)
Primary Purpose
AMD, Soft Drusen, Reticular Pseudodrusen
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Postbotics and Vitamins
Vitamins
Sponsored by
About this trial
This is an interventional treatment trial for AMD focused on measuring postbiotic, vitamins, drusen, intermediate AMD
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Sites / Locations
- Institut de la MaculaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
postbiotics with vitamins
vitamins
Arm Description
postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)
vitamins (AREDS formulation and recommended daily dose)
Outcomes
Primary Outcome Measures
Microperimetry
Median change difference in the % reduced threshold in microperimetry
Color vision change
Median change in red/green and yellow/blue color thresholds
Secondary Outcome Measures
Average Threshold microperimetry
Mean change of Average Threshold microperimetry
Best corrected visual acuity (BCVA)
Mean Change of Best corrected visual acuity (BCVA)
Low luminance visual acuity (LLVA)
Mean Change of Low luminance visual acuity (LLVA)
Rod and cone sensitivity
Mean change of Rod and cone sensitivity test
Advanced Vision and Optometric Test (AVOT)
Mean change AVOT vision test
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).
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).
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
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)
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
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
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
Change of SDD ribbon
Change of number SDD ribbon within the OCT cube as as per protocol
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)
Full Information
NCT ID
NCT05056025
First Posted
April 15, 2021
Last Updated
September 14, 2021
Sponsor
Institut de la Macula y la Retina
Collaborators
Igen BioLab SLU
1. Study Identification
Unique Protocol Identification Number
NCT05056025
Brief Title
Study to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration.
Acronym
REVERS
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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 establish the efficacy and safety of supplementation with postbiotics in patients with macular degeneration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AMD, Soft Drusen, Reticular Pseudodrusen, Drusen Stage Macular Degeneration, Drusen (Degenerative) of Macula, Bilateral
Keywords
postbiotic, vitamins, drusen, intermediate AMD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
postbiotics with vitamins
Arm Type
Experimental
Arm Description
postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)
Arm Title
vitamins
Arm Type
Placebo Comparator
Arm Description
vitamins (AREDS formulation and recommended daily dose)
Intervention Type
Dietary Supplement
Intervention Name(s)
Postbotics and Vitamins
Intervention Description
2 capsule 3 times a day, before meals
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamins
Intervention Description
2 capsule 3 times a day, before meals
Primary Outcome Measure Information:
Title
Microperimetry
Description
Median change difference in the % reduced threshold in microperimetry
Time Frame
12 months
Title
Color vision change
Description
Median change in red/green and yellow/blue color thresholds
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Average Threshold microperimetry
Description
Mean change of Average Threshold microperimetry
Time Frame
12 months
Title
Best corrected visual acuity (BCVA)
Description
Mean Change of Best corrected visual acuity (BCVA)
Time Frame
12 months
Title
Low luminance visual acuity (LLVA)
Description
Mean Change of Low luminance visual acuity (LLVA)
Time Frame
12 months
Title
Rod and cone sensitivity
Description
Mean change of Rod and cone sensitivity test
Time Frame
12 months
Title
Advanced Vision and Optometric Test (AVOT)
Description
Mean change AVOT vision test
Time Frame
12 months
Title
incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) conversion loci
Description
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).
Time Frame
12 months
Title
complete retinal pigment epithelial and outer retinal atrophy (cRORA) conversion loci
Description
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).
Time Frame
12 months
Title
Area of cumulative cRORA conversion
Description
Area of cumulative cRORA conversion as measured in mm2 by en face OCT projection scans of the OCT cube as as per protocol
Time Frame
12 months
Title
Hyperreflective dots(HRD)+ (retinal pigment epithelium)RPE defects areas conversion
Description
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)
Time Frame
12 months
Title
Change in outer nuclear layer (ONL) volume
Description
Change in outer nuclear layer (ONL) volume measured by the spectralis software after manually correction of the layer segmentation
Time Frame
12 months
Title
Change of drusen > 100 microns height
Description
Change of number of drusen of > 100 microns height measured by OCT within the OCT cube as as per protocol
Time Frame
12 months
Title
Change of subretinal drusenoid deposits (SDD) through ellipsoid zone (ELZ)
Description
Change of number of subretinal drusenoid deposits (SDD) through ellipsoid zone within the OCT cube as as per protocol
Time Frame
12 months
Title
Change of SDD ribbon
Description
Change of number SDD ribbon within the OCT cube as as per protocol
Time Frame
12 months
Title
Conversion to choroidal neovascularization (CNV)
Description
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)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordi Mones, MD PhD
Phone
+34 935 950 155
Email
jmones@institutmacula.com
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Garcia, OD, MSc
Phone
+34 935 950 155
Email
mgarcia@institutmacula.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordi Mones, MD, PhD
Organizational Affiliation
Institut de la Macula
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de la Macula
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordi M Mones, MD, PhD
Phone
+34935950155
Email
jmones@institutmacula.com
First Name & Middle Initial & Last Name & Degree
Marc Biarnes, OD, PhD
Phone
+34935950155
Email
mbiarnes@institutmacula.com
First Name & Middle Initial & Last Name & Degree
Jordi M Mones, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration.
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