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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: Probiotic Combination Cap/Tab; Drug: intravitreal Anti-VEGF injection

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Kwangsic Joo, MD PhD; Phone Number: 82-31-787-7387; Email: namooj@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of
    • Recruiting
    • Seoul National University Bundang Hospital
    • Contact: Kwangsic Joo, MD PhD; Phone Number: 82-31-787-7387; Email: namooj@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control patients, no oral probiotics supplement; 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.
Experimental: Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement; 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; The Perfect Probiotics® capsule will be given as an intervention, which is composed of mostly Lactobacillus acidophilus & Bifidobacterium lactis.; Other Names: The Perfect Probiotics®; Drug: intravitreal Anti-VEGF injection; Intravitreal anti-VEGF injection treatment in the neovascular AMD patients.
Sham Comparator: neovascular AMD patients with anti-VEGF treatment, no oral probiotics supplement; 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; Intravitreal anti-VEGF injection treatment in the neovascular AMD patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity changes after oral probiotics supplement	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).	6 months after enrollment

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Kwangsic Joo, MD PhD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: microbiome; neovascular AMD
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: AMDMICROBIOME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No