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

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.

Study Overview

• Status: Recruiting
• Conditions: AMD; Drusen Stage Macular Degeneration; Soft Drusen; Reticular Pseudodrusen; Drusen (Degenerative) of Macula, Bilateral
• Intervention / Treatment: Dietary supplement: Postbotics and Vitamins; Dietary supplement: Vitamins

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordi Mones, MD PhD; Phone Number: +34 935 950 155; Email: jmones@institutmacula.com
• Study Contact Backup: Name: Miriam Garcia, OD, MSc; Phone Number: +34 935 950 155; Email: mgarcia@institutmacula.com

Study Locations

• Spain
  • Barcelona, Spain, 08022
    • Recruiting
    • Institut de la Macula
    • Contact: Jordi M Mones, MD, PhD; Phone Number: +34935950155; Email: jmones@institutmacula.com
    • Contact: Marc Biarnes, OD, PhD; Phone Number: +34935950155; Email: mbiarnes@institutmacula.com
    • Principal Investigator: Jordi M Mones, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microperimetry	Median change difference in the % reduced threshold in microperimetry	12 months
Color vision change	Median change in red/green and yellow/blue color thresholds	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Threshold microperimetry	Mean change of Average Threshold microperimetry	12 months
Best corrected visual acuity (BCVA)	Mean Change of Best corrected visual acuity (BCVA)	12 months
Low luminance visual acuity (LLVA)	Mean Change of Low luminance visual acuity (LLVA)	12 months
Rod and cone sensitivity	Mean change of Rod and cone sensitivity test	12 months
Advanced Vision and Optometric Test (AVOT)	Mean change AVOT vision test	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).	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).	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	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)	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	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	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	12 months
Change of SDD ribbon	Change of number SDD ribbon within the OCT cube as as per protocol	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)	12 months

Collaborators and Investigators

• Sponsor: Institut de la Macula y la Retina
• Collaborators: Igen BioLab SLU

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 2, 2020
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): January 1, 2024

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (ACTUAL): September 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: postbiotic; vitamins; drusen; intermediate AMD
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Retinal Drusen; Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: 2020/79-MIN-HUGC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No