Parkinson DiseaseAMD-PARKNCT03415984
Prevalence of Age Related Macular Degeneration (ARMD) in Parkinson's Patients and Assesment of the Role of L-DOPA
An observational study of Parkinson Disease and Age Related Macular Degeneration, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Age related macular degeneration (ARMD) is a major and irreversible cause of blindness among the elderly. The sub-retinal space, located between the retinal pigmentary epithelium (RPE) and the external segments of the retinal photoreceptors, plays a crucial role in this pathology. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease, Age Related Macular Degeneration
- What is being tested?
- Color retinography, Optical coherence tomography and Fundus autofluorescence imaging
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2018to 15 Jan 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: Patients with Parkinson's disease, treated or not treated with L-DOPA
Who may be able to join
- Patients aged of 50 years old and more
- Parkinson's disease
Who cannot join
- Patient under a measure of legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prevalence of Age Related Macular Degeneration (ARMD) in Parkinson's Patients and Assesment of the Role of L-DOPA (AMD-PARK)
Age related macular degeneration (ARMD) is a major and irreversible cause of blindness among the elderly. The sub-retinal space, located between the retinal pigmentary epithelium (RPE) and the external segments of the retinal photoreceptors, plays a crucial role in this pathology. A recent epidemiologic study in the US, has shown that Parkinson patients treated with L-DOPA, developed only later an ARMD when compared to the untreated patients.
The L-Dopa is an endogenous ligand of the GPR43 receptor (G protein-coupled receptors), located on the RPE's cell's apical pole.
Read more
This receptor, via several intracellular mechanisms, regulates the cell's exosomal and endosomal pathways: it would appear that the L-DOPA, by stimulating this receptor, decreases significantly the RPE's exosome release.
The contents of the exosomes is still uncertain, however in addition to their signalization role, it seems they transport pro-inflammatory components, possibly helping the cellular recruitment due to the mononuclear phagocytic systems, particularly toxic for the photoreceptors.
The aim of this study is to estimate the prevalence of ARMD in a sample of Parkinson's Patients followed at Fondation Ophtalmologique Adolphe de Rothschild and to compared it to the prevalence of ARMD of the general population.
Furthermore the study aims to explore a possible causal link between L-DOPA treatment and ARMD.
- Being tested
- Color retinography, Optical coherence tomography, Fundus autofluorescence imaging
- Keywords
- Parkinson Disease, Age Related Macular Degeneration, L-DOPA
- Medical subject headings
- Parkinson Disease, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color retinographyDiagnostic test
Color retinography
Optical coherence tomographyDiagnostic test
Optical coherence tomography
Fundus autofluorescence imagingDiagnostic test
Fundus autofluorescence imaging
| Study group | Role | What they receive |
|---|---|---|
| Exposed patients | Patients with Parkinson's disease treated with L-DOPA Receives: Diagnostic Test: Color retinography; Diagnostic Test: Optical coherence tomography; Diagnostic Test: Fundus autofluorescence imaging | |
| Non exposed patients | Patients with Parkinson's disease not treated with L-DOPA Receives: Diagnostic Test: Color retinography; Diagnostic Test: Optical coherence tomography; Diagnostic Test: Fundus autofluorescence imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ARMD
Comparison of the percentage of patients with ARMD in both groups (Parkinson's Patients treated or not treated with L-DOPA) : Diagnosis of ARMD by the ophthalmologist is based on 3 exams (Color retinography, Optical coherence tomography and Fundus autofluorescence imaging). In case of any discrepancy between the results of the 3 exams, the final diagnosis of ARMD is based on the Optical coherence tomography.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start19 Jan 2018
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martine MAUGET FAYSSE, MD, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415984
- Sponsor's protocol ID
- MMT_2017_24
- Acronym
- AMD-PARK
- Status last verified
- Jan 2019
- First submitted
- 19 Jan 2018
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of Age Related Macular Degeneration (ARMD) in Parkinson's Patients and Assesment of the Role of L-DOPA (AMD-PARK)
- ClinicalTrials.gov ID
- NCT03415984
- Acronym / sponsor ID
- AMD-PARK / MMT_2017_24
- Keywords
- Parkinson Disease, Age Related Macular Degeneration, L-DOPA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 30 Jan 2018 (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 (ARMD) is a major and irreversible cause of blindness among the elderly. The sub-retinal space, located between the retinal pigmentary epithelium (RPE) and the external segments of the retinal photoreceptors, plays a crucial role in this pathology. A recent epidemiologic study in the US, has shown that Parkinson patients treated with L-DOPA, developed only later an ARMD when compared to the untreated patients.
The L-Dopa is an endogenous ligand of the GPR43 receptor (G protein-coupled receptors), located on the RPE's cell's apical pole.
This receptor, via several intracellular mechanisms, regulates the cell's exosomal and endosomal pathways: it would appear that the L-DOPA, by stimulating this receptor, decreases significantly the RPE's exosome release.
The contents of the exosomes is still uncertain, however in addition to their signalization role, it seems they transport pro-inflammatory components, possibly helping the cellular recruitment due to the mononuclear phagocytic systems, particularly toxic for the photoreceptors.
The aim of this study is to estimate the prevalence of ARMD in a sample of Parkinson's Patients followed at Fondation Ophtalmologique Adolphe de Rothschild and to compared it to the prevalence of ARMD of the general population.
Furthermore the study aims to explore a possible causal link between L-DOPA treatment and ARMD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed patients | – | Diagnostic Test: Color retinography, Diagnostic Test: Optical coherence tomography, Diagnostic Test: Fundus autofluorescence imagingPatients with Parkinson's disease treated with L-DOPA |
| Non exposed patients | – | Diagnostic Test: Color retinography, Diagnostic Test: Optical coherence tomography, Diagnostic Test: Fundus autofluorescence imagingPatients with Parkinson's disease not treated with L-DOPA |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease, treated or not treated with L-DOPA
Key inclusion criteria (2 listed)
- Patients aged of 50 years old and more
- Parkinson's disease
Key exclusion criteria (1 listed)
- Patient under a measure of legal protection
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 |
|---|---|---|
| Color retinographyColor retinography | Diagnostic test | Exposed patients, Non exposed patients |
| Optical coherence tomographyOptical coherence tomography | Diagnostic test | Exposed patients, Non exposed patients |
| Fundus autofluorescence imagingFundus autofluorescence imaging | Diagnostic test | Exposed patients, Non exposed patients |
Primary outcome
Prevalence of ARMD
Time frame: baseline
Comparison of the percentage of patients with ARMD in both groups (Parkinson's Patients treated or not treated with L-DOPA) : Diagnosis of ARMD by the ophthalmologist is based on 3 exams (Color retinography, Optical coherence tomography and Fundus autofluorescence imaging). In case of any discrepancy between the results of the 3 exams, the final diagnosis of ARMD is based on the Optical coherence tomography.
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 1 Feb 2019.
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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.
Martine MAUGET FAYSSE, MD principal investigator
Fondation Ophtalmologique A. de Rothschild
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 Parkinson Disease and Age Related Macular Degeneration, run by Fondation Ophtalmologique Adolphe de Rothschild 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 2 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 Feb 2019. 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?
Prevalence of ARMD (time frame: baseline). 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 1 Feb 2019.