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Age Related Macular DegenerationNCT02055612

Mobile Clinic - a Cross-sectional Epidemiological Survey

An observational study of Age Related Macular Degeneration, run by Novartis Slovakia, s.r.o. at 1 site in Slovakia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to find out prevalence of aged-related macular degeneration (AMD) in Slovak Republic. The outcome of the project will be epidemiology survey, prevalence of wet form of AMD in relation to demographic data, patient´s anamnesis, nutrition, co-morbidities etc. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Age Related Macular Degeneration
How many people
3,278 participants
Where
1 siteSlovakia
Study dates
Mar 2013to Jul 2013
Phase
Observational
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 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adults from general population across Slovak Republic over 55 years of age, predominantly with home base far than 35 km from nearest retina center

Who may be able to join

  • Adult patients (aged≥55 years) from selected areas in Slovak Republic
  • Patients with home base far than 35 km from the nearest center (centers: Bratislava, Nitra, Nové Zámky, Trenčín, Bojnice, Žilina, Martin, Ružomberok, Banská Bystrica, Zvolen, Poprad, Prešov, Košice, Trebišov)
  • Patient´s informed consent signed.

Who cannot join

  • Patients who do not meet the inclusion criteria

Trial locations and contacts

1 site in 1 country.

Slovakia1 site

  • Novartis Slovakia, s.r.o.

    Bratislava, 821 04

Other trials in Slovakia

About this study

Official title: Mobile Clinic- a Cross-sectional Epidemiological Survey to Investigate the Prevalence of Wet Aged-related Macular Degeneration (wAMD) in Elderly Population in Slovak Republic

The aim of the study is to find out prevalence of aged-related macular degeneration (AMD) in Slovak Republic. The outcome of the project will be epidemiology survey, prevalence of wet form of AMD in relation to demographic data, patient´s anamnesis, nutrition, co-morbidities etc.

Read the detailed description

It´s cross-sectional epidemiological survey, multi-centric, non-interventional

  1. Patients will fill a questionnaire with demography data, anamnesis, risk factors.
  2. Patients will be assessed by using Amsler grid.
  3. Patient´s back of the eye will be examined with fundus camera (searching for long-term back of the eye changes, retina vessels, macula and surrounding tissues) by retina specialist.
  4. Patient undergoes optical coherent tomography (OCT) examination (cross-section of fovea and macula) by retina specialist.

The project actively screen patients with wAMD. All patients will sign an informed consent.

The process of screening will be held in certain timeframe (cca. 2 months) and selected areas of Slovak Republic.

Keywords
wet AMD, epidemiology
Medical subject headings
Macular Degeneration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aged specific prevalence of aged-related macular degeneration

    Measured: participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria

Secondary outcomes (4)

  1. Social-demography structure of patients with wAMD

    Measured: participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria

  2. Risk factors associated with wAMD (e.g. co-morbidities, nutrition effects)

    Measured: participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria

  3. Relation between home distance of the patients with wAMD from the nearest center and availability of heath care

    Measured: participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria

  4. Other eye diseases during screening process

    Measured: participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2014 (estimated)
  2. Study startMar 2013
  3. Primary completionMay 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
3,278 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02055612
Sponsor's protocol ID
CRFB002ASK01 EPI
Status last verified
Feb 2017
First submitted
4 Feb 2014
Last updated
1 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Age Related Macular Degeneration, run by Novartis Slovakia, s.r.o. at 1 site in Slovakia.

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 3 inclusion and 1 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: finished, as of the sponsor's last update on 1 Mar 2017. 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 Slovakia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aged specific prevalence of aged-related macular degeneration (time frame: participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria). 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 NCT02055612.

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 1 Mar 2017.

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