Age-Related Macular DegenerationNCT05757674
Analysis of the Intestinal Microbiome in Patients With Wet Age-related Macular Degeneration
An observational study of Age-Related Macular Degeneration, run by University of Ioannina at 2 sites in Greece.
Trial summary
Analysis of the Intestinal Microbiome in Patients With Wet Age-related Macular Degeneration Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Sample examination
- How many people
- 130 participants
- Where
- 2 sitesGreece
- Study dates
- 10 Jan 2020to 20 Jun 2023
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Newly diagnosed patients with neovascular age-related macular degeneration from the area of North-West Greece
Who may be able to join
- Newly diagnosed neovascular age-related macular degeneration.
Who cannot join
- Chronic gastrointestinal disorders
Trial locations and contacts
2 sites in 1 country.
Greece2 sites, 2 recruiting
- Recruiting
University of Ioannina
Ioannina, Epirus, 451 10
Andreas Katsanos, 0030 26510 99142, katsanos@uoi.gr
- Recruiting
University of Ioannina
Ioannina, Epirus, 45110
Andreas Katsanos, Associate Professor of Ophth, 0030 26510 99142, katsanos@uoi.gr
About this study
Analysis of the Intestinal Microbiome in Patients With Wet Age-related Macular Degeneration
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Sample examination
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample examinationOther
No intervention will be performed
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients Receives: Other: Sample examination | |
| Control | Control Receives: Other: Sample examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal microbiome profile
Intestinal microbiome profile
Measured: 2022-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start10 Jan 2020
- Primary completion20 Jun 2023 (estimated)
- Study completion20 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Katsanos, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757674
- Sponsor's protocol ID
- 20(7)-15/4/2020.
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Katsanos A, Benekos K, Karavasili M, Gorgoli K, Kostoulas C, Gartzonika K, Christodoulou DK, Katsanos K, Georgiou I. Intestinal Microbiome of Newly Diagnosed Patients With Neovascular Age-Related Macular Degeneration: A 16S rRNA Gene Sequencing Study. Cureus. 2026 Feb 20;18(2):e103984. doi: 10.7759/cureus.103984. eCollection 2026 Feb.
PubMed 41873297
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Intestinal Microbiome in Patients With Wet Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05757674
- Acronym / sponsor ID
- 20(7)-15/4/2020.
- Conditions
- Age-Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 20 Jun 2023 (estimated)
- Study completion
- 20 Jun 2023 (estimated)
- First posted
- 7 Mar 2023 (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.
Analysis of the Intestinal Microbiome in Patients With Wet Age-related Macular Degeneration
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Sample examinationPatients |
| Control | – | Other: Sample examinationControl |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newly diagnosed patients with neovascular age-related macular degeneration from the area of North-West Greece
Key inclusion criteria (1 listed)
- Newly diagnosed neovascular age-related macular degeneration.
Key exclusion criteria (1 listed)
- Chronic gastrointestinal disorders
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 |
|---|---|---|
| Sample examinationNo intervention will be performed | Other | Control, Patients |
Primary outcome
Intestinal microbiome profile
Time frame: 2022-2023
Intestinal microbiome profile
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Derived from this study: PubMed 41873297Katsanos A, Benekos K, Karavasili M, Gorgoli K, Kostoulas C, Gartzonika K, Christodoulou DK, Katsanos K, Georgiou I. Intestinal Microbiome of Newly Diagnosed Patients With Neovascular Age-Related Macular Degeneration: A 16S rRNA Gene Sequencing Study. Cureus. 2026 Feb 20;18(2):e103984. doi: 10.7759/cureus.103984. eCollection 2026 Feb.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by University of Ioannina at 2 sites in Greece.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal microbiome profile (time frame: 2022-2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05757674, which also lists 1 linked publication.
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 7 Mar 2023.