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

NCT ID: NCT02102880

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2023-09-02

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.

Conditions

Age-Related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy Subjects

Group Type: OTHER

the polymerase chain reaction (PCR)

Intervention Type: GENETIC

Interventions

the polymerase chain reaction (PCR)

Intervention Type: GENETIC

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Gerhard Garhofer

Ass.Prof.Dr.med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Gerhard Garhofer, MD

Role: CONTACT

gerhard.garhoefer@meduniwien.ac.at

0034140400 ext. 2981

Facility Contacts

Gerhard Garhöfer, MD

Role: primary

gerhard.garhoefer@meduniwien.ac.at

0043140400 ext. 2981

References

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.

Reference Type: DERIVED

PMID: 29472236 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28898284 (View on PubMed)

Other Identifiers

OPHT-040214

Identifier Type: -

Identifier Source: org_study_id