Analysis of the Intestinal Microbiome in Patients With We... | NCT05757674

Studies
Analysis of the Intestinal Microbiome in Patients With Wet Age-related Macular Degeneration

NCT05757674

Sponsor

University of Ioannina

Status

Unknown status

Last Update Posted

Mar 7, 2023Actual

Enrollment

130Estimated

Phase

Not provided

Conditions

Age-Related Macular Degeneration

Interventions

Sample examination

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2020Actual

Primary Completion Date

Jun 20, 2023Estimated

Completion Date

Jun 20, 2023Estimated

First Submitted Date

Feb 23, 2023

First Submission Date that Met QC Criteria

Feb 23, 2023

First Posted Date

Mar 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2023

Last Update Posted Date

Mar 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andreas Katsanos, Associate Professor of Ophthalmology, University of IoanninaPrincipal Investigator

Lead Sponsor

University of IoanninaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		Patients	Other: Sample examination
Control		Control	Other: Sample examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sample examination	Other	No intervention will be performed	Control Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intestinal microbiome profile	Intestinal microbiome profile	2022-2023

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newly diagnosed neovascular age-related macular degeneration.

Exclusion Criteria:

Chronic gastrointestinal disorders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Newly diagnosed patients with neovascular age-related macular degeneration from the area of North-West Greece

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Ioannina	Recruiting	Ioannina	Epirus	451 10	Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41873297	Derived	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.

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases