Age-Related Macular DegenerationNCT01298674
Epidemiological Study of the Prevalence of Age-Related Macular Degeneration in Portugal
An observational study of Age-Related Macular Degeneration, run by Association for Innovation and Biomedical Research on Light and Image at 2 sites in Portugal.
Trial summary
This is an epidemiological study to assess the the prevalence of Age-Related Macular (ARM) Degeneration in Portugal. 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
- 6,023 participants
- Where
- 2 sitesPortugal
- Study dates
- Aug 2009to Oct 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: Participants with 55 or more years-old
Who may be able to join
- Participants with 55 years-old
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Health care units of Lousã and Trevim-Sol
Lousã, Coimbra District, 3200-201
ARS Centro - Centro de Saúde de Mira
Mira
About this study
This is an epidemiological study to assess the the prevalence of Age-Related Macular (ARM) Degeneration in Portugal.
- Conditions
- Age-Related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
ARM
Signs of Age-Related Macular Degeneration
Measured: 1 month after the screening
Secondary outcomes (1)
Other ocular disease
Signs of other ocular disease such as: diabetic retinopathy, glaucoma, cataract, etc.
Measured: 1 month after screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startAug 2009
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 6,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Cunha-Vaz, MD, PhD, Study director, Association for Innovation and Biomedical Research on Light and ImageRufino Silva, MD, PhD, Principal investigator, Association for Innovation and Biomedical Research on Light and Image
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298674
- Sponsor's protocol ID
- CC-01-2009
- Status last verified
- Jan 2017
- First submitted
- 15 Feb 2011
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Farinha C, Barreto P, Coimbra R, Machado MB, Figueiredo I, Cachulo ML, Cunha-Vaz J, Silva R. Age-Related Macular Degeneration and Extramacular Drusen: Genetic Associations in the Coimbra Eye Study. Invest Ophthalmol Vis Sci. 2024 May 1;65(5):35. doi: 10.1167/iovs.65.5.35.
PubMed 38776116
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of the Prevalence of Age-Related Macular Degeneration in Portugal
- ClinicalTrials.gov ID
- NCT01298674
- Acronym / sponsor ID
- CC-01-2009
- Conditions
- Age-Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,023 participants (actual)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Feb 2011 (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.
This is an epidemiological study to assess the the prevalence of Age-Related Macular (ARM) Degeneration in Portugal.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with 55 or more years-old
Key inclusion criteria (1 listed)
- Participants with 55 years-old
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ARM
Time frame: 1 month after the screening
Signs of Age-Related Macular Degeneration
1 secondary outcome
Other ocular disease
Time frame: 1 month after screening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Derived from this study: PubMed 38776116Farinha C, Barreto P, Coimbra R, Machado MB, Figueiredo I, Cachulo ML, Cunha-Vaz J, Silva R. Age-Related Macular Degeneration and Extramacular Drusen: Genetic Associations in the Coimbra Eye Study. Invest Ophthalmol Vis Sci. 2024 May 1;65(5):35. doi: 10.1167/iovs.65.5.35.
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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.
José Cunha-Vaz, MD, PhD study director
Association for Innovation and Biomedical Research on Light and Image
Rufino Silva, MD, PhD principal investigator
Association for Innovation and Biomedical Research on Light and Image
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by Association for Innovation and Biomedical Research on Light and Image at 2 sites in Portugal.
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 1 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 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
ARM (time frame: 1 month after the screening). 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 NCT01298674, which also lists 1 linked publication.
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 5 Jan 2017.