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
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.
- 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