Age-Related Macular DegenerationAMDIncidencePTNCT02748824
Five-year Incidence of Age-related Macular Degeneration in the Central Region of Portugal
An observational study of Age-Related Macular Degeneration, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
Trial summary
To assess the five-year incidence of AMD in a population from the central region of Portugal, previously phenotypically characterized. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- How many people
- 5,996 participants
- Where
- 1 sitePortugal
- Study dates
- Jul 2016to 31 Oct 2017
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of male and female subjects who have participated and phenotyped in the Epidemiologic Coimbra Eye Study (NTC01298674). It is expected to recruit up to a total of 5.996 subjects, that is up to 2.975 subjects from the Mira Healthcare Unit and up to 3.021 subjects from the Lousã Healthcare Unit.
Who may be able to join
- Subjects who participated in the Epidemiologic Coimbra Eye Study (NCT01298674) and that were phenotyped;
- Subjects capable of understanding the information about the study and to give their informed consent to enter the study;
- Subjects willing and able to comply with the study procedures.
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
To assess the five-year incidence of AMD in a population from the central region of Portugal, previously phenotypically characterized.
Read the detailed description
Subjects who participated in the Epidemiologic Coimbra Eye Study (NCT01298674) between 2009 and 2013 will attend a single visit, after giving informed consent.
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Age- Related Macular Degeneration; Diabetic Retinopathy; Glaucoma; Cataract
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy, Glaucoma, Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotypic classification of AMD in the five-year clinical visit. Comparison of this classification with the grading of 5 years ago.
Measured: 5 years
Secondary outcomes (1)
Risk factors: Demographic, Medical history, Ophthalmologic history, Family history of AMD, Systemic comorbidities and medication, Nutritional and Lifestyle habits. Signs of AMD on the multimodal evaluation.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startJul 2016
- Primary completion18 Sep 2017
- Study completion31 Oct 2017
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,996 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
- Rufino Silva, PhD, Principal investigator, Association for Innovation and Biomedical Research on Light and Image
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748824
- Sponsor's protocol ID
- 4C-2016-09
- Other IDs
- AMDIncidence-CPT
- Acronym
- AMDIncidencePT
- Status last verified
- Nov 2017
- First submitted
- 20 Apr 2016
- Last updated
- 9 Nov 2017
- Results posted
- No
Publications
Barreto P, Farinha C, Coimbra R, Cachulo ML, Melo JB, Lechanteur Y, Hoyng CB, Cunha-Vaz J, Silva R. Interaction between genetics and the adherence to the Mediterranean diet: the risk for age-related macular degeneration. Coimbra Eye Study Report 8. Eye Vis (Lond). 2023 Aug 14;10(1):38. doi: 10.1186/s40662-023-00355-0.
PubMed 37580831
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five-year Incidence of Age-related Macular Degeneration in the Central Region of Portugal
- ClinicalTrials.gov ID
- NCT02748824
- Acronym / sponsor ID
- AMDIncidencePT / 4C-2016-09
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Age- Related Macular Degeneration; Diabetic Retinopathy; Glaucoma; Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,996 participants (actual)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 22 Apr 2016 (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.
To assess the five-year incidence of AMD in a population from the central region of Portugal, previously phenotypically characterized.
Detailed description
Subjects who participated in the Epidemiologic Coimbra Eye Study (NCT01298674) between 2009 and 2013 will attend a single visit, after giving informed consent.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of male and female subjects who have participated and phenotyped in the Epidemiologic Coimbra Eye Study (NTC01298674). It is expected to recruit up to a total of 5.996 subjects, that is up to 2.975 subjects from the Mira Healthcare Unit and up to 3.021 subjects from the Lousã Healthcare Unit.
Key inclusion criteria (3 listed)
- Subjects who participated in the Epidemiologic Coimbra Eye Study (NCT01298674) and that were phenotyped;
- Subjects capable of understanding the information about the study and to give their informed consent to enter the study;
- Subjects willing and able to comply with the study procedures.
Key exclusion criteria (1 listed)
- Not applicable
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
Phenotypic classification of AMD in the five-year clinical visit. Comparison of this classification with the grading of 5 years ago.
Time frame: 5 years
1 secondary outcome
Risk factors: Demographic, Medical history, Ophthalmologic history, Family history of AMD, Systemic comorbidities and medication, Nutritional and Lifestyle habits. Signs of AMD on the multimodal evaluation.
Time frame: 5 years
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 9 Nov 2017.
- Derived from this study: PubMed 37580831Barreto P, Farinha C, Coimbra R, Cachulo ML, Melo JB, Lechanteur Y, Hoyng CB, Cunha-Vaz J, Silva R. Interaction between genetics and the adherence to the Mediterranean diet: the risk for age-related macular degeneration. Coimbra Eye Study Report 8. Eye Vis (Lond). 2023 Aug 14;10(1):38. doi: 10.1186/s40662-023-00355-0.
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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.
Rufino Silva, PhD principal investigator
Association for Innovation and Biomedical Research on Light and Image
1 site 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 1 site 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 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 9 Nov 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 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?
Phenotypic classification of AMD in the five-year clinical visit. Comparison of this classification with the grading of 5 years ago. (time frame: 5 years). 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 NCT02748824, 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 9 Nov 2017.