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

NCT05604989 | Completed Phase 3

• 1 other identifier: AMDMICROBIOME
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.15 neovascular AMD patients with anti-VEGF treatment and oral probiotics supplement
2. 2.15 neovascular AMD patients with anti-VEGF treatment and no oral probiotics supplement
3. 3.15 control patients and no oral probiotics supplement

Conditions

Neovascular Age-related Macular Degeneration

Keywords

neovascular AMD; microbiome

Outcome Measures

Primary Outcomes (2)

• Oral microbiome changes after oral probiotics supplement in neovascular AMD patients

  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.

  6 months after enrollment

• Intestinal microbiome changes after oral probiotics supplement in neovascular AMD patients

  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.

  6 months after enrollment

Secondary Outcomes (1)

• Visual acuity changes after oral probiotics supplement

  6 months after enrollment

Study Arms (3)

Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement

EXPERIMENTAL

Neovascular AMD patients will be allocated. Regular intravitreal anti-VEGF injection treatment will be done. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis. Oral probiotics (The Perfect Probiotics®) supplement will be given to the participants for 6 months.

Drug: Probiotic Combination Cap/Tab; Drug: intravitreal Anti-VEGF injection

neovascular AMD patients with anti-VEGF treatment, no oral probiotics supplement

SHAM COMPARATOR

Neovascular AMD patients will be allocated. Regular intravitreal anti-VEGF injection treatment will be done. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis. No Oral probiotics (The Perfect Probiotics®) supplement in this group.

Drug: intravitreal Anti-VEGF injection

Control patients, no oral probiotics supplement

NO INTERVENTION

Healthy, no retinal disease patients will be allocated. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis. No Oral probiotics (The Perfect Probiotics®) supplement in this group.

Interventions

Probiotic Combination Cap/Tab DRUG

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

Also known as: The Perfect Probiotics®

Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement

intravitreal Anti-VEGF injection DRUG

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

Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement; neovascular AMD patients with anti-VEGF treatment, no oral probiotics supplement

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Study Officials

• Kwangsic Joo, MD PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Deparment of Ophthalmology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: November 3, 2022
• Study Start: January 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: November 30, 2024
• Last Updated: May 16, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)