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

Not Applicable

• Conditions: Age-Related Macular Degeneration
• Interventions: Genetic: the polymerase chain reaction (PCR)

• Registration Number: NCT02102880
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-03
• Study Start: 2015-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07
• Primary Completion: 2023-09-02
• Study Completion: 2023-09-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Subjects	the polymerase chain reaction (PCR)	-

Primary Outcome Measures

Name	Time	Method
Choroidal blood flow during isometric exercise (LDF)	1 day

Secondary Outcome Measures

Name	Time	Method
Laser Speckle Flowmetry (LSFG)	1 day
Flicker induced vasodilatation, expressed as percent change to baseline (DVA)	1 day
Genotyping (PCR)	1 day
Retinal vessel calibers and AV- ratio (DVA)	1 day

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria