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

NCT ID: NCT02438111

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2023-12-31

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 .

Detailed Description

Age-related macular degeneration (AMD) is the most frequent cause of blindness in the elderly. Despite major research efforts in the last decades the etiology of AMD remains largely undefined and therefore treatment options are only very limited. However, there is evidence that nutrition and inflammation play a role in the pathogenesis of AMD . The latter is also corroborated by the finding that single nucleotide polymorphism in the gene encoding complement factor H is associated with AMD . In addition to CHF other genes such as ARMS2, C3, PLEKHA1, HTRA-1, VEGF-A, VEGF-B, VEGFR and APOE have been associated with development of AMD. Recent findings have implicated the gut microbiota as a contributor of metabolic diseases through the modulation of host metabolism and inflammation . Gut bacteria use mostly fermentation to generate energy, converting sugars, in part, to short-chain fatty acid, that are used by the host as energy source. Beyond short-chain fatty acids gut bacteria can provide some amino acids and contribute certain vitamins such as biotin to the host . The investigators propose to investigate whether compositional and functional alterations of the gut microbiota are a risk factor for developing AMD.

Conditions

Age Related Macular Degeneration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

age related macular degeneration

metagenome AMD

metagenome

Intervention Type: GENETIC

metagenome

controls

metagenome controls

metagenome

Intervention Type: GENETIC

metagenome

Interventions

metagenome

metagenome

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Zinkernagel, M.D, PhD

Role: STUDY_CHAIR

Department of Ophthalmology, University Hospital Bern, Switzerland

Martin S Zinkernagel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, University Hospital Bern, Switzerland

Martin Fiedler, MD

Role: STUDY_DIRECTOR

University Hospital Bern, Switzerland

Locations

Inselspital Bern, Department of Ophthalmology

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

KEK BE 205/13, PB_2016-01922

Identifier Type: -

Identifier Source: org_study_id