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

Study Overview
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Brief Summary
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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. 15 neovascular AMD patients with anti-VEGF treatment and oral probiotics supplement 15 neovascular AMD patients with anti-VEGF treatment and no oral probiotics supplement 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.

Official Title
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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

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Probiotic Combination Cap/Tab
* Drug: intravitreal Anti-VEGF injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neovascular AMD, microbiome