NCT02102880

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2023

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

8.5 years

First QC Date

March 21, 2014

Last Update Submit

April 6, 2022

Conditions

Age-Related Macular Degeneration

Keywords

Genetic Association Studies

Outcome Measures

Primary Outcomes (1)

  • Choroidal blood flow during isometric exercise (LDF)

    1 day

Secondary Outcomes (4)

  • Flicker induced vasodilatation, expressed as percent change to baseline (DVA)

    1 day

  • Genotyping (PCR)

    1 day

  • Retinal vessel calibers and AV- ratio (DVA)

    1 day

  • Laser Speckle Flowmetry (LSFG)

    1 day

Study Arms (1)

Healthy Subjects

OTHER
Genetic: the polymerase chain reaction (PCR)

Interventions

the polymerase chain reaction (PCR)GENETIC
Healthy Subjects

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (2)

  • 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.

    PMID: 29472236DERIVED

  • 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.

    PMID: 28898284DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Central Study Contacts

Gerhard Garhofer, MD

CONTACT

0034140400gerhard.garhoefer@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.Dr.med.

Study Record Dates

First Submitted

March 21, 2014

First Posted

April 3, 2014

Study Start

March 1, 2015

Primary Completion

September 2, 2023

Study Completion

September 2, 2023

Last Updated

April 7, 2022

Record last verified: 2022-04

Locations

AU(1)