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

Neovascular Age-related Macular Degeneration Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05604989
• Other study ID #: AMDMICROBIOME
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Seoul National University Bundang Hospital
• Contact: Kwangsic Joo, MD PhD
• Phone: 82-31-787-7387
• Email: namooj[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Probiotic Combination Cap/Tab
The Perfect Probiotics® capsule will be given as an intervention, which is composed of mostly Lactobacillus acidophilus & Bifidobacterium lactis.
• intravitreal Anti-VEGF injection
Intravitreal anti-VEGF injection treatment in the neovascular AMD patients.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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