The Role of the Gut Metagenome on the Development of Age Related Macular Degeneration (AMD)

NCT02438111 | Unknown

• 1 other identifier: KEK BE 205/13, PB_2016-01922
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess whether compositional and functional alterations of the gut metagenome may be related to AMD. The primary variable for this assessment is the composition of the gut metagenome which will be analyzed by shotgun sequencing to characterize the faecal metagenome. The secondary endpoint is to assess whether single nucleotide polymorphisms in CFH, ARMS2, C3, PLEKHA1, HTRA-1, VEGF-A, VEGF-B, VEGFR and APOE genes which have been shown to be risk factors for the development of AMD and other macular diseases correlate with alterations in the gut metagenome .

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• taxonomic and functional characterization of gut microbiota

  3 years

Secondary Outcomes (2)

• Gut-microbiota-based AMD classification

  3 years

• AMD-associated gut microbial markers

  3 years

Study Arms (2)

age related macular degeneration

metagenome AMD

Genetic: metagenome

controls

metagenome controls

Genetic: metagenome

Interventions

metagenome GENETIC

metagenome

age related macular degeneration; controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with age related macular degeneration (AMD)

You may qualify if:

• Subject must be willing to give written informed consent and willing to provide blood and stool probes
• Patients with clinically confirmed AMD 18 years of age or greater
• Probands with no signs of AMD 18 years of age or greater

You may not qualify if:

• Smoking
• Chronic inflammatory disease (autoimmune diseases such as rheumatoid arthritis, lupus erythematodes, chronic inflammatory bowel disease)
• Diabetes as defined by The World Health Organization (WHO) criteria
• Treated hyperlipidemia
• Obesity with a body mass index (BMI) greater than or equal to 30
• Recent (3 month) history of use of systemic antibiotics
• Opacities of ocular media excluding detailed observation of the retina

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital Bern, Department of Ophthalmology

Bern, 3010, Switzerland

Location

Related Publications (1)

• Sporri L, Studer JM, Kreuzer M, Rotzetter J, Scharer D, Largiader CR, Jaggi D, Zinkernagel MS, Zysset-Burri DC. Linking the microbiome to the complement system in geographic atrophy. NPJ Genom Med. 2026 Feb 2. doi: 10.1038/s41525-026-00550-7. Online ahead of print.

  PMID: 41629364 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood serum/ stool

MeSH Terms

Conditions

Macular Degeneration

Interventions

Metagenome

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Genome; Genetic Structures; Genetic Phenomena

Study Officials

• Martin Zinkernagel, M.D, PhD

  Department of Ophthalmology, University Hospital Bern, Switzerland

  STUDY CHAIR

• Martin S Zinkernagel, MD, PhD

  Department of Ophthalmology, University Hospital Bern, Switzerland

  PRINCIPAL INVESTIGATOR

• Martin Fiedler, MD

  University Hospital Bern, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 8, 2015
• Study Start: December 1, 2013
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CH (1)