Associations Between the Oral and Intestinal Microbiome 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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05604989

Enrollment

Registered

2022-11-03

Start date

2023-01-01

Completion date

2024-11-30

Last updated

2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Age-related Macular Degeneration

Keywords

neovascular AMD, microbiome

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.

Interventions

DRUGProbiotic Combination Cap/Tab

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

DRUGintravitreal Anti-VEGF injection

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026