The Role of Complement Factor H Polymorphism in the Regulation of Choroidal Vascular Tone in Young Healthy Subjects

Age-Related Macular Degeneration Clinical Trial

Official title:

The Role of Complement Factor H Polymorphism in the Regulation of Choroidal Vascular Tone in Young Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02102880
• Other study ID #: OPHT-040214
• Status: Recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: September 2, 2023

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: Gerhard Garhofer, MD
• Phone: 0034140400
• Email: gerhard.garhoefer[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic component. Given that it is known that impaired regulation of choroidal vascular tone is present in patients with AMD, the current study seeks to investigate whether genetic polymorphisms in risk alleles for AMD are associated with altered choroidal blood flow regulation in healthy subjects. For this purpose a total of 220 healthy volunteers will be included. Choroidal blood flow regulation will be evaluated by measuring choroidal blood flow during isometric exercise. In addition, flicker induced vasodilatation will be studied and retinal vessel calibers will assessed, as well as retinal thickness and macular pigment optical density.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: September 2, 2023
• Est. primary completion date: September 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Men and women aged between 18 and 45 years, nonsmokers

• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

• Systolic blood pressure < 160 mmHg, diastolic blood pressure < 90 mmHg

• Normal ophthalmic findings, ametropia less than 3 diopters

Exclusion Criteria:

• Regular use of medication

• Abuse of alcoholic beverages

• Participation in a clinical trial in the 3 weeks preceding the study

• Treatment in the previous 3 weeks with any drug (except hormonal contraceptives)

• Symptoms of a clinically relevant illness in the 3 weeks before the first study day

• Blood donation during the previous 3 weeks

• History or family history of epilepsy

• Pregnancy, planned pregnancy or lactating

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Genetic:
• the polymerase chain reaction (PCR)

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choroidal blood flow during isometric exercise (LDF)		1 day
Secondary	Flicker induced vasodilatation, expressed as percent change to baseline (DVA)		1 day
Secondary	Genotyping (PCR)		1 day
Secondary	Retinal vessel calibers and AV- ratio (DVA)		1 day
Secondary	Laser Speckle Flowmetry (LSFG)		1 day