ClinicalTrials.Veeva

Menu

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

I

Institut de la Macula y la Retina

Status

Active, not recruiting

Conditions

Age-Related Macular Degeneration
Geographic Atrophy

Treatments

Dietary Supplement: postbiotics (IGENH35.3A)
Dietary Supplement: vitamins (AREDS formulation and recommended daily dose)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05391074
InstitutMaculaRetina

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

55 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

patients with GA secondary to AMD, myopia or angioid streaks
Experimental group
Description:
postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)
Treatment:
Dietary Supplement: postbiotics (IGENH35.3A)
Dietary Supplement: vitamins (AREDS formulation and recommended daily dose)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems