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

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ClinicalTrials.gov Identifier: NCT02102880
Recruitment Status : Recruiting
First Posted : April 3, 2014
Last Update Posted : January 9, 2018
Information provided by (Responsible Party):
Gerhard Garhofer, 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.

Condition or disease Intervention/treatment
Age-Related Macular Degeneration Genetic: the polymerase chain reaction (PCR)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Role of Complement Factor H Polymorphism in the Regulation of Choroidal Vascular Tone in Young Healthy Subjects
Actual Study Start Date : March 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Healthy Subjects Genetic: the polymerase chain reaction (PCR)

Primary Outcome Measures :
  1. Choroidal blood flow during isometric exercise (LDF) [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Flicker induced vasodilatation, expressed as percent change to baseline (DVA) [ Time Frame: 1 day ]
  2. Genotyping (PCR) [ Time Frame: 1 day ]
  3. Retinal vessel calibers and AV- ratio (DVA) [ Time Frame: 1 day ]
  4. Laser Speckle Flowmetry (LSFG) [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102880

Contact: Gerhard Garhofer, MD 0034140400 ext 2981 gerhard.garhoefer@meduniwien.ac.at

Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhöfer, MD    0043140400 ext 2981    gerhard.garhoefer@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerhard Garhofer, Ass.Prof.Dr.med., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02102880     History of Changes
Other Study ID Numbers: OPHT-040214
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Keywords provided by Gerhard Garhofer, Medical University of Vienna:
Genetic Association Studies

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Complement System Proteins
Complement Factor H
Immunologic Factors
Physiological Effects of Drugs
Complement Inactivating Agents
Immunosuppressive Agents