search
Back to results

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

Primary Purpose

Age-Related Macular Degeneration

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
the polymerase chain reaction (PCR)
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Age-Related Macular Degeneration focused on measuring Genetic Association Studies

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Clinical Pharmacology, Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Healthy Subjects

Arm Description

Outcomes

Primary Outcome Measures

Choroidal blood flow during isometric exercise (LDF)

Secondary Outcome Measures

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

Full Information

First Posted
March 21, 2014
Last Updated
April 6, 2022
Sponsor
Medical University of Vienna
search

1. Study Identification

Unique Protocol Identification Number
NCT02102880
Brief Title
The Role of Complement Factor H Polymorphism in the Regulation of Choroidal Vascular Tone in Young Healthy Subjects
Official Title
The Role of Complement Factor H Polymorphism in the Regulation of Choroidal Vascular Tone in Young Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2015 (Actual)
Primary Completion Date
September 2, 2023 (Anticipated)
Study Completion Date
September 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
Genetic Association Studies

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Subjects
Arm Type
Other
Intervention Type
Genetic
Intervention Name(s)
the polymerase chain reaction (PCR)
Primary Outcome Measure Information:
Title
Choroidal blood flow during isometric exercise (LDF)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Flicker induced vasodilatation, expressed as percent change to baseline (DVA)
Time Frame
1 day
Title
Genotyping (PCR)
Time Frame
1 day
Title
Retinal vessel calibers and AV- ratio (DVA)
Time Frame
1 day
Title
Laser Speckle Flowmetry (LSFG)
Time Frame
1 day

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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhard Garhofer, MD
Phone
0034140400
Ext
2981
Email
gerhard.garhoefer@meduniwien.ac.at
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhöfer, MD
Phone
0043140400
Ext
2981
Email
gerhard.garhoefer@meduniwien.ac.at

12. IPD Sharing Statement

Citations:
PubMed Identifier
29472236
Citation
Calzetti G, Fondi K, Bata AM, Luft N, Wozniak PA, Witkowska KJ, Bolz M, Popa-Cherecheanu A, Werkmeister RM, Schmidl D, Garhofer G, Schmetterer L. Assessment of choroidal blood flow using laser speckle flowgraphy. Br J Ophthalmol. 2018 Dec;102(12):1679-1683. doi: 10.1136/bjophthalmol-2017-311750. Epub 2018 Feb 22.
Results Reference
derived
PubMed Identifier
28898284
Citation
Witkowska KJ, Bata AM, Calzetti G, Luft N, Fondi K, Wozniak PA, Schmidl D, Bolz M, Popa-Cherecheanu A, Werkmeister RM, Garhofer G, Schmetterer L. Optic nerve head and retinal blood flow regulation during isometric exercise as assessed with laser speckle flowgraphy. PLoS One. 2017 Sep 12;12(9):e0184772. doi: 10.1371/journal.pone.0184772. eCollection 2017.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs