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Trial record 1 of 1 for:    NCT05056025
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Study to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration. (REVERS)

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ClinicalTrials.gov Identifier: NCT05056025
Recruitment Status : Recruiting
First Posted : September 24, 2021
Last Update Posted : September 24, 2021
Sponsor:
Collaborator:
Igen BioLab SLU
Information provided by (Responsible Party):
Jordi Mones MD PhD, Institut de la Macula y la Retina

Tracking Information
First Submitted Date  ICMJE April 15, 2021
First Posted Date  ICMJE September 24, 2021
Last Update Posted Date September 24, 2021
Actual Study Start Date  ICMJE December 2, 2020
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2021)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2021)
  • Average Threshold microperimetry [ Time Frame: 12 months ]
    Mean change of Average Threshold microperimetry
  • Best corrected visual acuity (BCVA) [ Time Frame: 12 months ]
    Mean Change of Best corrected visual acuity (BCVA)
  • Low luminance visual acuity (LLVA) [ Time Frame: 12 months ]
    Mean Change of Low luminance visual acuity (LLVA)
  • Rod and cone sensitivity [ Time Frame: 12 months ]
    Mean change of Rod and cone sensitivity test
  • Advanced Vision and Optometric Test (AVOT) [ Time Frame: 12 months ]
    Mean change AVOT vision test
  • incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) conversion loci [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 12 months ]
    Change of number SDD ribbon within the OCT cube as as per protocol
  • Conversion to choroidal neovascularization (CNV) [ Time Frame: 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration.
Official Title  ICMJE A PILOT STUDY TO EVALUATE THE PROGRESSION OF THE DISEASE AND RESPONSE TO SUPPLEMENTATION WITH POSTBIOTICS IGEN-0222 IN PATIENTS WITH MACULAR DEGENERATION
Brief Summary A pilot study to establish the efficacy and safety of supplementation with postbiotics in patients with macular degeneration.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • AMD
  • Soft Drusen
  • Reticular Pseudodrusen
  • Drusen Stage Macular Degeneration
  • Drusen (Degenerative) of Macula, Bilateral
Intervention  ICMJE
  • Dietary Supplement: Postbotics and Vitamins
    2 capsule 3 times a day, before meals
  • Dietary Supplement: Vitamins
    2 capsule 3 times a day, before meals
Study Arms  ICMJE
  • Experimental: postbiotics with vitamins
    postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)
    Intervention: Dietary Supplement: Postbotics and Vitamins
  • Placebo Comparator: vitamins
    vitamins (AREDS formulation and recommended daily dose)
    Intervention: Dietary Supplement: Vitamins
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2021)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jordi Mones, MD PhD +34 935 950 155 jmones@institutmacula.com
Contact: Miriam Garcia, OD, MSc +34 935 950 155 mgarcia@institutmacula.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05056025
Other Study ID Numbers  ICMJE 2020/79-MIN-HUGC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Jordi Mones MD PhD, Institut de la Macula y la Retina
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Institut de la Macula y la Retina
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Igen BioLab SLU
Investigators  ICMJE
Principal Investigator: Jordi Mones, MD, PhD Institut de la Macula
PRS Account Institut de la Macula y la Retina
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP