Age Related Macular DegenerationPANDANCT03035461
Patient's Feelings After Receiving a Diagnosis of Age-related Macular Degeneration
An observational study of Age Related Macular Degeneration, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly population of the industrialized world. AMD is a progressive degenerative disease affecting the central area of the retina, responsible for distinct vision. 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
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2017to 19 Oct 2018
- 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: Patients with a diagnosis of wet AMD seen in the ophtalmologic department of the CHI creteil
Who may be able to join
- patient up to 55 years old
- wet AMD
- diagnostic questionnaire group: patient being announced with AMD for less than 1 month
- disease course questionnaire group: patients treated by anti-VEGF from 6 to 12 months
Who cannot join
- dry AMD
- patient under 55 years old
- patient who doesn't speak French
- patient carrying an ophtalmologic genetic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ressenti du Patient au Moment de l'Annonce du Diagnostic de DMLA
Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly population of the industrialized world. AMD is a progressive degenerative disease affecting the central area of the retina, responsible for distinct vision. Vision loss arises from aberrant new vessel growth which causes the accumulation of blood or fluid within the retina's thickness and eventually leads to permanent scarring. The two major forms of AMD are exudative, or neovascular or "wet", and non-exudative, or "dry".
Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat wet-AMD.
Read more
After diagnosis and explanations of the practionner, the patients and their close relatives have still frequently many questions about the intravitreal injections, the prognosis, the risk of visual impairment, etc. Few teams have studied the modalities of diagnosis announcement and the understanding of the patients on the disease course.
The aim of this study is to evaluate the feelings after the AMD diagnosis announcement as well as the understanding of the possibilities of treatment and the clinical surveillance.
- Conditions
- Age Related Macular Degeneration
- Keywords
- diagnosis annoucement, patient's feelings
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the patient's feelings
A questionnaire with a list of different feelings: anxiety, distress, relief, resigned, guilty, etc. is proposed to the patient after AMD diagnosis. they can also explain their feelings by themselves.
Measured: up to 1 month after diagnosis
Secondary outcomes (9)
score of general satisfaction
the patient will score their satisfaction on a numeric scale from 0 (not satisfied at all) to 10 (extremely satisfied)
Measured: up to 1 month after diagnosis
score on a comprehension quiz on AMD
Measured: up to 1 month after diagnosis
Score on a composite score evaluating the clarity of medical explanations
Measured: up to 1 month after diagnosis
Score on a composite score evaluating the clarity of medical explanations
Measured: between 6 months and 1 year of follow-up
score of satisfaction of announcement conditions
Measured: up to 1 month after diagnosis
score of satisfaction of announcement conditions
Measured: between 6 months and 1 year of follow-up
score of satisfactions regarding the clarity of the disease course and treatment explanations
Measured: between 6 months and 1 year of follow-up
Score on the anxiety PHQ9 questionnaire
Measured: between 6 months and 1 year of follow-up
Score on the anxiety GAD7 questionnaire
Measured: between 6 months and 1 year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start15 Mar 2017
- Primary completion1 Feb 2018
- Study completion19 Oct 2018
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.
- 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joëlle Marciano, Centre Hospitalier Intercommunal Creteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035461
- Sponsor's protocol ID
- PANDA
- Acronym
- PANDA
- Status last verified
- Jul 2020
- First submitted
- 25 Jan 2017
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ressenti du Patient au Moment de l'Annonce du Diagnostic de DMLA
- ClinicalTrials.gov ID
- NCT03035461
- Acronym / sponsor ID
- PANDA / PANDA
- Conditions
- Age Related Macular Degeneration
- Keywords
- diagnosis annoucement, patient's feelings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 30 Jan 2017 (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 the leading cause of blindness in the elderly population of the industrialized world. AMD is a progressive degenerative disease affecting the central area of the retina, responsible for distinct vision. Vision loss arises from aberrant new vessel growth which causes the accumulation of blood or fluid within the retina's thickness and eventually leads to permanent scarring. The two major forms of AMD are exudative, or neovascular or "wet", and non-exudative, or "dry".
Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat wet-AMD.
After diagnosis and explanations of the practionner, the patients and their close relatives have still frequently many questions about the intravitreal injections, the prognosis, the risk of visual impairment, etc. Few teams have studied the modalities of diagnosis announcement and the understanding of the patients on the disease course.
The aim of this study is to evaluate the feelings after the AMD diagnosis announcement as well as the understanding of the possibilities of treatment and the clinical surveillance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of wet AMD seen in the ophtalmologic department of the CHI creteil
Key inclusion criteria (4 listed)
- patient up to 55 years old
- wet AMD
- diagnostic questionnaire group: patient being announced with AMD for less than 1 month
- disease course questionnaire group: patients treated by anti-VEGF from 6 to 12 months
Key exclusion criteria (4 listed)
- dry AMD
- patient under 55 years old
- patient who doesn't speak French
- patient carrying an ophtalmologic genetic disorder
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
Description of the patient's feelings
Time frame: up to 1 month after diagnosis
A questionnaire with a list of different feelings: anxiety, distress, relief, resigned, guilty, etc. is proposed to the patient after AMD diagnosis. they can also explain their feelings by themselves.
9 secondary outcomes
score of general satisfaction
Time frame: up to 1 month after diagnosis
score on a comprehension quiz on AMD
Time frame: up to 1 month after diagnosis
Score on a composite score evaluating the clarity of medical explanations
Time frame: up to 1 month after diagnosis
Score on a composite score evaluating the clarity of medical explanations
Time frame: between 6 months and 1 year of follow-up
score of satisfaction of announcement conditions
Time frame: up to 1 month after diagnosis
score of satisfaction of announcement conditions
Time frame: between 6 months and 1 year of follow-up
score of satisfactions regarding the clarity of the disease course and treatment explanations
Time frame: between 6 months and 1 year of follow-up
Score on the anxiety PHQ9 questionnaire
Time frame: between 6 months and 1 year of follow-up
Score on the anxiety GAD7 questionnaire
Time frame: between 6 months and 1 year of follow-up
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 4 Aug 2020.
- Individual participant dataSharing planned: No
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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 Intercommunal Creteil 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 4 inclusion and 4 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 4 Aug 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?
Description of the patient's feelings (time frame: up to 1 month after diagnosis). 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 4 Aug 2020.