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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02102880
• Collaborator: (none)
• Enrollment: 220
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 102.1
• Patients Per Site Per Month: 2.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration	Genetic: the polymerase chain reaction (PCR)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 220 participants
• Allocation: N/A
• 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: Mar 1, 2015
• Anticipated Primary Completion Date: Sep 2, 2023
• Anticipated Study Completion Date: Sep 2, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Choroidal blood flow during isometric exercise (LDF) [1 day]

Secondary Outcome Measures

1. Flicker induced vasodilatation, expressed as percent change to baseline (DVA) [1 day]

2. Genotyping (PCR) [1 day]

3. Retinal vessel calibers and AV- ratio (DVA) [1 day]

4. Laser Speckle Flowmetry (LSFG) [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Pharmacology, Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gerhard Garhofer, Ass.Prof.Dr.med., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT02102880
• Other Study ID Numbers: OPHT-040214
• First Posted: Apr 3, 2014
• Last Update Posted: Apr 7, 2022
• Last Verified: Apr 1, 2022

• Keywords provided by Gerhard Garhofer, Ass.Prof.Dr.med., Medical University of Vienna: Genetic Association Studies
• Additional relevant MeSH terms: Macular Degeneration

Study Results

No Results Posted as of Apr 7, 2022