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

Phase 3

Completed

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

• Registration Number: NCT05604989
• Lead Sponsor: Seoul National University Bundang Hospital

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-11-01
• Study First Posted: 2022-11-03
• Study Start: 2023-01-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement	Probiotic Combination Cap/Tab	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.
neovascular AMD patients with anti-VEGF treatment, no oral probiotics supplement	intravitreal Anti-VEGF injection	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.
Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement	intravitreal Anti-VEGF injection	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.

Primary Outcome Measures

Name	Time	Method
Oral microbiome changes after oral probiotics supplement in neovascular AMD patients	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.
Intestinal microbiome changes after oral probiotics supplement in neovascular AMD patients	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 Outcome Measures

Name	Time	Method
Visual acuity changes after oral probiotics supplement	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).

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of