Associations Between the Oral and Intestinal Microbiome and Neovascular Age-related Macular Degen… (NCT05604989) | Clinical Trial Compass
CompletedPhase 3
Associations Between the Oral and Intestinal Microbiome and Neovascular Age-related Macular Degeneration
South Korea45 participantsStarted 2023-01-01
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oral microbiome changes after oral probiotics supplement in neovascular AMD patients
Timeframe: 6 months after enrollment
2
Intestinal microbiome changes after oral probiotics supplement in neovascular AMD patients