The Role of Complement Factor H Polymorphism in the Regul... | NCT02102880

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

NCT02102880

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Apr 7, 2022Actual

Enrollment

220Estimated

Phase

Not Applicable

Conditions

Age-Related Macular Degeneration

Interventions

the polymerase chain reaction (PCR)

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015Actual

Primary Completion Date

Sep 2, 2023Estimated

Completion Date

Sep 2, 2023Estimated

First Submitted Date

Mar 21, 2014

First Submission Date that Met QC Criteria

Mar 31, 2014

First Posted Date

Apr 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2022

Last Update Posted Date

Apr 7, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gerhard Garhofer, Ass.Prof.Dr.med., Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Label	Type	Description	Intervention Names
Healthy Subjects	Other		Genetic: the polymerase chain reaction (PCR)

Name	Type	Description	Arm Group Labels	Other Names
the polymerase chain reaction (PCR)	Genetic		Healthy Subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Choroidal blood flow during isometric exercise (LDF)		1 day

Secondary Outcomes

Measure	Description	Time Frame
Flicker induced vasodilatation, expressed as percent change to baseline (DVA)		1 day
Genotyping (PCR)		1 day
Retinal vessel calibers and AV- ratio (DVA)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gerhard Garhofer, MD	Contact	0034140400	2981	gerhard.garhoefer@meduniwien.ac.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Pharmacology, Medical University of Vienna	Recruiting	Vienna		1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29472236	Derived	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.
28898284	Derived

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases