Does Complement Factor H Gene Polymorphism Play a Role in the Regulation of Vascular Tone in the Choroid?

NCT ID: NCT00708929

Last Updated: 2013-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-12-31

Brief Summary

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Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic component. Most importantly a genetic polymorphism in the gene encoding for the complement factor H (CFH) has been recently identified which is highly associated with an increased risk of developing AMD. This Tyr402His polymorphism located on chromosome 1q31 has been implicated to play a role in the development of the disease.

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 the Tyr402His polymorphism is associated with altered choroidal autoregulation in healthy subjects. For this purpose a total of 100 healthy volunteers will be included in order to test the hypothesis that an impaired regulation of choroidal blood flow is present in subjects with homozygous Tyr402His variant.

Detailed Description

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Conditions

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Genetic Polymorphism Macular Degeneration Regional Blood Flow Ocular Physiology

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

14 subjects homozygous HH for the Tyr402His single nucleotide polymorphism

Group Type OTHER

Squatting

Intervention Type PROCEDURE

Squatting for 6 minutes

2

14 subjects homozygous TT for the Tyr402His single nucleotide polymorphism

Group Type OTHER

Squatting

Intervention Type PROCEDURE

Squatting for 6 minutes

Interventions

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Squatting

Squatting for 6 minutes

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Men and women aged between 18 and 35 years
* Nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropy 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
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Garhofer

Ass.Prof.Priv.Doz.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerhard Garhöfer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT-040607

Identifier Type: -

Identifier Source: org_study_id

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