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

• ClinicalTrials.gov Identifier: NCT05391074
• Recruitment Status: Active, not recruiting
• First Posted: May 25, 2022
• Last Update Posted: June 24, 2022
• Sponsor: Institut de la Macula y la Retina
• Collaborator: Igen BioLab SLU
• Information provided by (Responsible Party): Institut de la Macula y la Retina

Tracking Information

• First Submitted Date: May 20, 2022
• First Posted Date: May 25, 2022
• Last Update Posted Date: June 24, 2022
• Actual Study Start Date: December 1, 2020
• Estimated Primary Completion Date: December 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oral Postbiotics in Patients With Macular Atrophy
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Geographic Atrophy
• Age-Related Macular Degeneration

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: May 20, 2022): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2024
• Estimated Primary Completion Date: December 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 55 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT05391074
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Institut de la Macula y la Retina
• Original Responsible Party: Same as current
• Current Study Sponsor: Institut de la Macula y la Retina
• Original Study Sponsor: Same as current
• Collaborators: Igen BioLab SLU

Investigators

• Principal Investigator: Jordi Monés, MD, PhD; Institut de la Màcula

• PRS Account: Institut de la Macula y la Retina
• Verification Date: June 2022