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Oral Postbiotics in Patients With Macular Atrophy (REVERS-GA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05391074
Recruitment Status : Active, not recruiting
First Posted : May 25, 2022
Last Update Posted : June 24, 2022
Sponsor:
Collaborator:
Igen BioLab SLU
Information provided by (Responsible Party):
Institut de la Macula y la Retina

Tracking Information
First Submitted Date  ICMJE May 20, 2022
First Posted Date  ICMJE May 25, 2022
Last Update Posted Date June 24, 2022
Actual Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2022)
  • rate of growth of geographic atrophy (GA) as per SQRT (square roor transformation) of area of GA measured in FAF, (fundus autofluorescence) [ Time Frame: 12 months ]
    rate of growth of GA as per SQRT of FAF area compared to rate of growth of the previous year
  • safety and tolerability [ Time Frame: 12 months ]
    safety and tolerability of daily dosing of oral postbiotics assessed by number of patients with clinically significant changes of a combination of ocular and/or non-ocular adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2022)
  • rate of growth of geographic atrophy as per SQRT [ Time Frame: 12 months ]
    rate of growth of GA as per SQRT of FAF area compared to rate of growth of the previous year
  • safety and tolerability [ Time Frame: 12 months ]
    safety and tolerability of daily dosing of oral postbiotics assessed by Incidence and/or clinically significant changes of a combination of ocular and non-ocular adverse events
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Postbiotics in Patients With Macular Atrophy
Official Title  ICMJE Pilot Study to Evaluate the Safety and Efficacy of Oral Therapy With Postbiotics in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration, Myopia, or Angioid Streaks
Brief Summary A pilot study to evaluate the safety and efficacy of oral therapy with Postbiotics in patients with geographic atrophy secondary to age-related macular degeneration, myopia, or angioid streaks.
Detailed Description

A pilot study to evaluate the safety and efficacy of oral therapy with Postbiotics in patients with geographic atrophy (GA) secondary to age-related macular degeneration, myopia or angioid streaks.

The study's main objective is to evaluate if oral postbiotic therapy will induce epigenetic factors that would impact the progression of the GA, and it will compare the rate of growth of GA from the Baseline to 12 months, to the rate shown during the 12 months before Baseline.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Geographic Atrophy
  • Age-Related Macular Degeneration
Intervention  ICMJE
  • Dietary Supplement: postbiotics (IGENH35.3A)
    postbiotics to induce microbiota epigenetic factors
  • Dietary Supplement: vitamins (AREDS formulation and recommended daily dose)
    vitamins (AREDS to prevent AMD progression
Study Arms  ICMJE Experimental: patients with GA secondary to AMD, myopia or angioid streaks
postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)
Interventions:
  • Dietary Supplement: postbiotics (IGENH35.3A)
  • Dietary Supplement: vitamins (AREDS formulation and recommended daily dose)
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2022)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2024
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with GA secondary to AMD, myopia or angioid streaks
  • with 12 months of previous follow-up,
  • and a known progression of >0,20mm/year as per SQRT

Exclusion Criteria:

- history of choroidal neovascularization in the study eye

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05391074
Other Study ID Numbers  ICMJE InstitutMaculaRetina
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 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 Monés, MD, PhD Institut de la Màcula
PRS Account Institut de la Macula y la Retina
Verification Date June 2022

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