REVERS: Study to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration.

Sponsor

Institut de la Macula y la Retina (Other)

Overall Status

Recruiting

CT.gov ID

NCT05056025

Collaborator

Igen BioLab SLU (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A pilot study to establish the efficacy and safety of supplementation with postbiotics in patients with macular degeneration.

Condition or Disease	Intervention/Treatment	Phase
AMD Soft Drusen Reticular Pseudodrusen Drusen Stage Macular Degeneration Drusen (Degenerative) of Macula, Bilateral	Dietary Supplement: Postbotics and Vitamins Dietary Supplement: Vitamins	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 2, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: postbiotics with vitamins postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)	Dietary Supplement: Postbotics and Vitamins 2 capsule 3 times a day, before meals
Placebo Comparator: vitamins vitamins (AREDS formulation and recommended daily dose)	Dietary Supplement: Vitamins 2 capsule 3 times a day, before meals

Arm

Intervention/Treatment

Experimental: postbiotics with vitamins

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

Dietary Supplement: Postbotics and Vitamins

2 capsule 3 times a day, before meals

Placebo Comparator: vitamins

vitamins (AREDS formulation and recommended daily dose)

Dietary Supplement: Vitamins

2 capsule 3 times a day, before meals

Outcome Measures

Primary Outcome Measures

Microperimetry [12 months]
Median change difference in the % reduced threshold in microperimetry
Color vision change [12 months]
Median change in red/green and yellow/blue color thresholds

Secondary Outcome Measures

Average Threshold microperimetry [12 months]
Mean change of Average Threshold microperimetry
Best corrected visual acuity (BCVA) [12 months]
Mean Change of Best corrected visual acuity (BCVA)
Low luminance visual acuity (LLVA) [12 months]
Mean Change of Low luminance visual acuity (LLVA)
Rod and cone sensitivity [12 months]
Mean change of Rod and cone sensitivity test
Advanced Vision and Optometric Test (AVOT) [12 months]
Mean change AVOT vision test
incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) conversion loci [12 months]
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 [12 months]
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 [12 months]
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 [12 months]
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 [12 months]
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 [12 months]
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) [12 months]
Change of number of subretinal drusenoid deposits (SDD) through ellipsoid zone within the OCT cube as as per protocol
Change of SDD ribbon [12 months]
Change of number SDD ribbon within the OCT cube as as per protocol
Conversion to choroidal neovascularization (CNV) [12 months]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.