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

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Gerhard Garhofer, Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02102880
First received: March 21, 2014
Last updated: December 1, 2016
Last verified: December 2016
  Purpose
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 Intervention
Age-Related Macular Degeneration Genetic: the polymerase chain reaction (PCR)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Role of Complement Factor H Polymorphism in the Regulation of Choroidal Vascular Tone in Young Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Gerhard Garhofer, Medical University of Vienna:

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

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

Estimated Enrollment: 220
Study Start Date: March 2015
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Healthy Subjects Genetic: the polymerase chain reaction (PCR)

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102880

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

Locations
Austria
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
  More Information

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
Study First Received: March 21, 2014
Last Updated: December 1, 2016

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

ClinicalTrials.gov processed this record on September 19, 2017