Back to resultsDoes Complement Factor H Gene Polymorphism Play a Role in the Regulation of Vascular Tone in the Choroid?
Primary Purpose
Genetic Polymorphism, Macular Degeneration, Regional Blood Flow
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Squatting
Sponsored by
About this trial
This is an interventional basic science trial for Genetic Polymorphism focused on measuring Age-related macular degeneration, Complement factor H, Choroidal blood flow
Eligibility Criteria
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
Sites / Locations
- Department of Clinical Pharmacology, Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
14 subjects homozygous HH for the Tyr402His single nucleotide polymorphism
14 subjects homozygous TT for the Tyr402His single nucleotide polymorphism
Outcomes
Primary Outcome Measures
Choroidal blood flow during isometric exercise
Tyr402His genotyping
Secondary Outcome Measures
Mean arterial pressure
Intraocular pressure
Systolic/diastolic blood pressure
Pulse rate
Full Information
NCT ID
NCT00708929
First Posted
July 1, 2008
Last Updated
March 15, 2013
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00708929
Brief Title
Does Complement Factor H Gene Polymorphism Play a Role in the Regulation of Vascular Tone in the Choroid?
Official Title
Does Complement Factor H Gene Polymorphism Play a Role in the Regulation of Vascular Tone in the Choroid?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Polymorphism, Macular Degeneration, Regional Blood Flow, Ocular Physiology
Keywords
Age-related macular degeneration, Complement factor H, Choroidal blood flow
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
14 subjects homozygous HH for the Tyr402His single nucleotide polymorphism
Arm Title
2
Arm Type
Other
Arm Description
14 subjects homozygous TT for the Tyr402His single nucleotide polymorphism
Intervention Type
Procedure
Intervention Name(s)
Squatting
Intervention Description
Squatting for 6 minutes
Primary Outcome Measure Information:
Title
Choroidal blood flow during isometric exercise
Time Frame
10 minutes
Title
Tyr402His genotyping
Time Frame
screening
Secondary Outcome Measure Information:
Title
Mean arterial pressure
Time Frame
20 minutes
Title
Intraocular pressure
Time Frame
before and after blood flow measurements
Title
Systolic/diastolic blood pressure
Time Frame
20 minutes
Title
Pulse rate
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhöfer, MD
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Does Complement Factor H Gene Polymorphism Play a Role in the Regulation of Vascular Tone in the Choroid?
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