Age-related Macular DegenerationQUASARNCT03242083
Evaluate the Quality of Life of Patients With AMD
An observational study of Age-related Macular Degeneration, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Age-related macular degeneration (AMD) is a major cause of deep visual acuity loss. Because of progressive deterioration of the macula, patients with AMD complain about progressive visual problems that can impair their quality of life in the physical, mental and social domains. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- quality of life questionnaire
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2017to 3 Dec 2019
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: During an ophthalmology consultation, the clinician who has established the diagnosis of primary atrophic or secondarily atrophic AMD (defined in 1.1.2) proposes to the patient fulfilling the aforementioned eligibility criteria to participate in the study.
Who may be able to join
- For the 2 populations studied
- Persons who have given consent to take part
- Persons aged 50 years or older
- Willing and able to attend all of the scheduled visits and evaluations
- Macular atrophy or drusen measuring at least 125μm or multiple drusens measuring at least 63μm
- Atrophic AMD diagnosed on OCT and by autofluorescence and OCT angiography by 2 independent experienced assessors
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- Diagnosed for less than 3 years
- MAVC score ≥ 19 letters (Equivalent Snellen ≥ 20/400), by using a scale at an initial distance of 4m
- For patients with secondary atrophic AMD
- Secondary atrophic AMD, defined by persistent atrophic AMD at 1 year after the last injection of an anti-angiogenic agent, and at least 2 years after the first injection.
Who cannot join
- General criteria
- Persons without national health insurance cover
- Physical or mental disability ruling out participation
- Inability to sign the written consent form, adults under guardianship
- Any participation in a study involving an experimental drug during the previous 3 months (dietary supplements are authorised).
- Adults under guardianship
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- General medical history
- Uncontrolled AHT
- Ophthalmological history
- Severe non-proliferative or proliferative diabetic retinopathy
- Uncontrolled glaucoma (defined as an intra-ocular pressure greater than 30mmHg despite treatment with an anti-glaucoma agent) or a history of filtration surgery
- Corneal disease that could impair vision
- Monogenic macular dystrophy or toxic maculopathy
- History of uveitis
- Amblyopia of the eye concerned
- Intraocular surgery in the 3 months preceding inclusion
- History of cornea transplantation in the studied eye
- Treatment affecting vision: chloroquine and hydroxychloroquine, phenothiazine, tamoxifen, interferon (93), external radiotherapy of the face and neck
- Ophthalmological examination
- Significant cataract (LOCS III grade of 5 or above, annexe 5.) (94)
- Active infection in either eye
- Central anterior serous or active retinopathy in either eye
- Choroid neo-vascularisation
- Active serous retinal detachment
- Refractive error less than -15D or more than +10D
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation de la Quality of Life in Secondary Atrophic Age-related Macular Degeneration
Age-related macular degeneration (AMD) is a major cause of deep visual acuity loss. Because of progressive deterioration of the macula, patients with AMD complain about progressive visual problems that can impair their quality of life in the physical, mental and social domains. The principal objective principal of this study is to describe the evolution of quality of life between the diagnosis of secondary atrophic AMD and at 18 months after confirmation of diagnosis.
- Conditions
- Age-related Macular Degeneration
- Being tested
- quality of life questionnaire
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life questionnaireOther
quality of life questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Primary atrophic AMD | Not described Receives: Other: quality of life questionnaire | |
| Secondary atrophic AMD | Not described Receives: Other: quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
responses to a quality of life questionnaire
Measured: Change compared with baseline score at month 6, month 12 and month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start8 Aug 2017
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242083
- Sponsor's protocol ID
- KAUFFMANN PCA 2016
- Acronym
- QUASAR
- Status last verified
- Jan 2020
- First submitted
- 4 Aug 2017
- Last updated
- 23 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de la Quality of Life in Secondary Atrophic Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT03242083
- Acronym / sponsor ID
- QUASAR / KAUFFMANN PCA 2016
- Conditions
- Age-related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 8 Aug 2017 (actual)
- 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 major cause of deep visual acuity loss. Because of progressive deterioration of the macula, patients with AMD complain about progressive visual problems that can impair their quality of life in the physical, mental and social domains. The principal objective principal of this study is to describe the evolution of quality of life between the diagnosis of secondary atrophic AMD and at 18 months after confirmation of diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary atrophic AMD | – | Other: quality of life questionnaire |
| Secondary atrophic AMD | – | Other: quality of life questionnaire |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- During an ophthalmology consultation, the clinician who has established the diagnosis of primary atrophic or secondarily atrophic AMD (defined in 1.1.2) proposes to the patient fulfilling the aforementioned eligibility criteria to participate in the study.
Key inclusion criteria (10 listed)
- For the 2 populations studied
- Persons who have given consent to take part
- Persons aged 50 years or older
- Willing and able to attend all of the scheduled visits and evaluations
- Macular atrophy or drusen measuring at least 125μm or multiple drusens measuring at least 63μm
Key exclusion criteria (25 listed)
- General criteria
- Persons without national health insurance cover
- Physical or mental disability ruling out participation
- Inability to sign the written consent form, adults under guardianship
- Any participation in a study involving an experimental drug during the previous 3 months (dietary supplements are authorised).
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 |
|---|---|---|
| quality of life questionnairequality of life questionnaire | Other | Primary atrophic AMD, Secondary atrophic AMD |
Primary outcome
responses to a quality of life questionnaire
Time frame: Change compared with baseline score at month 6, month 12 and month 18
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 23 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Centre Hospitalier Universitaire Dijon at 1 site in France.
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 10 inclusion and 25 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 23 Jan 2020. 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 France. 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?
responses to a quality of life questionnaire (time frame: Change compared with baseline score at month 6, month 12 and month 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2020.