Neovascular Age-related Macular DegenerationPhase 3NCT05604989
Associations Between the Oral and Intestinal Microbiome and Neovascular Age-related Macular Degeneration
A Phase 3 study testing Probiotic Combination Cap/Tab and intravitreal Anti-VEGF injection in people with Neovascular Age-related Macular Degeneration, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Probiotic Combination Cap/Tab and intravitreal Anti-VEGF injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2023to 30 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal BMI patients
- Diagnosed as neovascular AMD (experimental \& sham group)
- Normal patients (control group)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Probiotic Combination Cap/Tab, intravitreal Anti-VEGF injection
- Keywords
- neovascular AMD, microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Combination Cap/TabDrug
Also called The Perfect Probiotics®
The Perfect Probiotics® capsule will be given as an intervention, which is composed of mostly Lactobacillus acidophilus \& Bifidobacterium lactis.
intravitreal Anti-VEGF injectionDrug
Intravitreal anti-VEGF injection treatment in the neovascular AMD patients.
| Study group | Role | What they receive |
|---|---|---|
| Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement | Experimental | 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. Receives: Drug: Probiotic Combination Cap/Tab; Drug: intravitreal Anti-VEGF injection |
| neovascular AMD patients with anti-VEGF treatment, no oral probiotics supplement | Sham comparator | 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. Receives: Drug: intravitreal Anti-VEGF injection |
| Control patients, no oral probiotics supplement | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months after enrollment
Secondary outcomes (1)
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).
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Jan 2023
- Primary completion31 Aug 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KWANGSIC JOO, Seoul National University Bundang Hospital
- Investigators
- Kwangsic Joo, MD PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604989
- Sponsor's protocol ID
- AMDMICROBIOME
- Status last verified
- Dec 2024
- First submitted
- 17 Oct 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05604989
- Acronym / sponsor ID
- AMDMICROBIOME
- Keywords
- neovascular AMD, microbiome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement | Experimental | Drug: Probiotic Combination Cap/Tab, Drug: intravitreal Anti-VEGF injectionNeovascular 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 | Sham comparator | Drug: intravitreal Anti-VEGF injectionNeovascular 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. |
| Control patients, no oral probiotics supplement | No intervention | –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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal BMI patients
- Diagnosed as neovascular AMD (experimental \& sham group)
- Normal patients (control group)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Combination Cap/TabAlso: The Perfect Probiotics®The Perfect Probiotics® capsule will be given as an intervention, which is composed of mostly Lactobacillus acidophilus \& Bifidobacterium lactis. | Drug | Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement |
| intravitreal Anti-VEGF injectionIntravitreal anti-VEGF injection treatment in the neovascular AMD patients. | Drug | Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement, neovascular AMD patients with anti-VEGF treatment, no oral probiotics supplement |
Primary outcome
Oral microbiome changes after oral probiotics supplement in neovascular AMD patients
Time frame: 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
Time frame: 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.
1 secondary outcome
Visual acuity changes after oral probiotics supplement
Time frame: 6 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwangsic Joo, MD PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic Combination Cap/Tab and intravitreal Anti-VEGF injection in people with Neovascular Age-related Macular Degeneration, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral microbiome changes after oral probiotics supplement in neovascular AMD patients (time frame: 6 months after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.