Age-Related Macular DegenerationNCT02102880
The Role of Complement Factor H Polymorphism in the Regulation of Choroidal Vascular Tone in Young Healthy Subjects
A study testing the polymerase chain reaction (PCR) in people with Age-Related Macular Degeneration, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- the polymerase chain reaction (PCR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2015to 2 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
Gerhard Garhöfer, MD, 0043140400 ext. 2981, gerhard.garhoefer@meduniwien.ac.at
About this study
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
- Being tested
- the polymerase chain reaction (PCR)
- Keywords
- Genetic Association Studies
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the polymerase chain reaction (PCR)Genetic
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Other | Not described Receives: Genetic: the polymerase chain reaction (PCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal blood flow during isometric exercise (LDF)
Measured: 1 day
Secondary outcomes (4)
Flicker induced vasodilatation, expressed as percent change to baseline (DVA)
Measured: 1 day
Genotyping (PCR)
Measured: 1 day
Retinal vessel calibers and AV- ratio (DVA)
Measured: 1 day
Laser Speckle Flowmetry (LSFG)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startMar 2015
- Primary completion2 Sep 2023 (estimated)
- Study completion2 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102880
- Sponsor's protocol ID
- OPHT-040214
- Status last verified
- Apr 2022
- First submitted
- 21 Mar 2014
- Last updated
- 7 Apr 2022
- Results posted
- No
Publications
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.
PubMed 29472236Witkowska 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.
PubMed 28898284
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Complement Factor H Polymorphism in the Regulation of Choroidal Vascular Tone in Young Healthy Subjects
- ClinicalTrials.gov ID
- NCT02102880
- Acronym / sponsor ID
- OPHT-040214
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Genetic Association Studies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 2 Sep 2023 (estimated)
- Study completion
- 2 Sep 2023 (estimated)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Other | Genetic: the polymerase chain reaction (PCR) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the polymerase chain reaction (PCR) | Genetic | Healthy Subjects |
Primary outcome
Choroidal blood flow during isometric exercise (LDF)
Time frame: 1 day
4 secondary outcomes
Flicker induced vasodilatation, expressed as percent change to baseline (DVA)
Time frame: 1 day
Genotyping (PCR)
Time frame: 1 day
Retinal vessel calibers and AV- ratio (DVA)
Time frame: 1 day
Laser Speckle Flowmetry (LSFG)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 29472236Calzetti 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.
- Derived from this study: PubMed 28898284Witkowska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the polymerase chain reaction (PCR) in people with Age-Related Macular Degeneration, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Garhofer, MD (0034140400 ext. 2981, gerhard.garhoefer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choroidal blood flow during isometric exercise (LDF) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02102880, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.