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Completed

NCT Number: NCT05604989

Associations Between the Oral and Intestinal Microbiome and Neovascular Age-related Macular Degeneration

A pilot study for Associations between the oral and intestinal microbiome and neovascular age-related macular degeneration and the investigation on the effect of oral probiotics as a treatment

The investigators recruit the neovascular AMD patients and control patients.

1. 15 neovascular AMD patients with anti-VEGF treatment and oral probiotics supplement 2. 15 neovascular AMD patients with anti-VEGF treatment and no oral probiotics supplement 3. 15 control patients and no oral probiotics supplement

The investigators will collect stool, blood, and saliva sample at the baseline and 6 months, and analyze the oral and intestinal microbiome changes.

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal BMI patients
  • Diagnosed as neovascular AMD (experimental & sham group)
  • Normal patients (control group)

Exclusion criteria

  • Obese (BMI > 30)
  • Past surgical history involving intestinal diseases
  • Previous oral antibiotic treatment before 1 week at the baseline enroll
  • Previous oral probiotics supplement
  • Previous ophthalmic retinal diseases except neovascular AMD

Treatment and study plan

Probiotic Combination Cap/Tab

Drug

The Perfect Probiotics® capsule will be given as an intervention, which is composed of mostly Lactobacillus acidophilus & Bifidobacterium lactis.

Other names: The Perfect Probiotics®

intravitreal Anti-VEGF injection

Drug

Intravitreal anti-VEGF injection treatment in the neovascular AMD patients.

Primary outcomes

  1. Oral microbiome changes after oral probiotics supplement in neovascular AMD patients

    Time frame: 6 months after enrollment

    The investigators will analyze the oral microbiome changes (baseline and 6 months after taking oral probiotics) in experimental, sham, and control groups.

    Microbiome relative abundance changes in percentage (%) will be statistically analyzed between baseline and 6 months.

  2. Intestinal microbiome changes after oral probiotics supplement in neovascular AMD patients

    Time frame: 6 months after enrollment

    The investigators will analyze the intestinal microbiome changes (baseline and 6 months after taking oral probiotics) in experimental, sham, and control groups.

    Microbiome relative abundance changes in percentage (%) will be statistically analyzed between baseline and 6 months.

Secondary outcomes

  1. Visual acuity changes after oral probiotics supplement

    Time frame: 6 months after enrollment

    If possible, visual acuity difference between experimental and sham group (oral probiotics vs. no oral probiotics) in the neovascular AMD patients.

    Visual acuity will be measured by the ETDRS eye chart (scale : letters).

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Associations Between the Oral and Intestinal Microbiome and Neovascular Age-related Macular Degeneration and the Investigation on the Effect of Oral Probiotics as a Treatment - A Pilot Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 3, 2022
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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