Macular Degeneration, SenilePARMNCT02863640
Evaluation of the Protective Role of the L-DOPA Against Age Related Macular Degeneration in Parkinson's Patients
An observational study of Macular Degeneration, Senile, 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 70 years and older
- Conditions the study is for
- Macular Degeneration, Senile
- What is being tested?
- Color retinography, Optical coherence tomography and Fundus autofluorescence imaging
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2015to 18 Dec 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Population of patients followed at Rothschild's Ophthalmologic Foundation for Parkinson's disease. The study is proposed to patients aged of 70 years old and more and with a cumulative dose of L-DOPA above the 59 th percentile of the population or with with a cumulative dose of L-DOPA below the 41th percentile of the population
Who may be able to join
- Patients aged of 70 years old and more
- Parkinson's disease
Who cannot join
- Opposition to participate in this trial
- Patient under a measure of legal protection
- Absence of affiliation to social security or universal health coverage (CMU)
Trial locations and contacts
1 site in 1 country.
About this study
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 A recent epidemiologic study in the US, unpublished yet, has shown that patients treated with the L-DOPA, developed only later an ARMD when compared to the untreated patients.
The L-Dopa is an endogenous ligand of the GPR43 receptor, 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 validate the hypothesis stating that he L-DOPA would play a protective role against age related macular degeneration.
- Conditions
- Macular Degeneration, Senile
- Being tested
- Color retinography, Optical coherence tomography, Fundus autofluorescence imaging
- Keywords
- Senile macular degeneration, Parkinson's disease
- Medical subject headings
- Macular Degeneration, Age-Related, 2, Macular Degeneration, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color retinographyDevice
Optical coherence tomographyDevice
Fundus autofluorescence imagingDevice
| Study group | Role | What they receive |
|---|---|---|
| Exposed patients | Patients treated for Parkinson's disease with a cumulative dose of L-DOPA above the 59th percentile of the population Receives: Device: Color retinography; Device: Optical coherence tomography; Device: Fundus autofluorescence imaging | |
| Non exposed patients | Patients treated for Parkinson's disease with a cumulative dose of L-DOPA below the 41th percentile of the population Receives: Device: Color retinography; Device: Optical coherence tomography; Device: Fundus autofluorescence imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of ARMD based on ophtalmological examination combining color retinography, optical coherence tomography and fundus autofluorescence Imaging
Risk of ARMD : Ratio between the ARMD prevalence rate in patients with an elevated cumulated dose of L-DOPA and the ARMD prevalence rate in patients with a low cumulated dose of L-DOPA Risk adjusted according to age and sexe
Measured: Diagnosis of ARMD made during a single consultation lasting about an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start14 Dec 2015
- Primary completion18 Dec 2017
- Study completion18 Dec 2017
Why it stopped: Major difficulties of patient inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Degeneration, SenileStudies 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
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martine MAUGET FAYSSE, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863640
- Sponsor's protocol ID
- MMT_2015_33
- Acronym
- PARM
- Status last verified
- Jan 2018
- First submitted
- 3 Aug 2016
- Last updated
- 8 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Protective Role of the L-DOPA Against Age Related Macular Degeneration in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT02863640
- Acronym / sponsor ID
- PARM / MMT_2015_33
- Conditions
- Macular Degeneration, Senile
- Keywords
- Senile macular degeneration, Parkinson's disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Major difficulties of patient inclusions
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 14 Dec 2015 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 11 Aug 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.
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, unpublished yet, has shown that patients treated with the L-DOPA, developed only later an ARMD when compared to the untreated patients.
The L-Dopa is an endogenous ligand of the GPR43 receptor, 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 validate the hypothesis stating that he L-DOPA would play a protective role against age related macular degeneration.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed patients | – | Device: Color retinography, Device: Optical coherence tomography, Device: Fundus autofluorescence imagingPatients treated for Parkinson's disease with a cumulative dose of L-DOPA above the 59th percentile of the population |
| Non exposed patients | – | Device: Color retinography, Device: Optical coherence tomography, Device: Fundus autofluorescence imagingPatients treated for Parkinson's disease with a cumulative dose of L-DOPA below the 41th percentile of the population |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Population of patients followed at Rothschild's Ophthalmologic Foundation for Parkinson's disease. The study is proposed to patients aged of 70 years old and more and with a cumulative dose of L-DOPA above the 59 th percentile of the population or with with a cumulative dose of L-DOPA below the 41th percentile of the population
Key inclusion criteria (2 listed)
- Patients aged of 70 years old and more
- Parkinson's disease
Key exclusion criteria (3 listed)
- Opposition to participate in this trial
- Patient under a measure of legal protection
- Absence of affiliation to social security or universal health coverage (CMU)
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 retinography | Device | Exposed patients, Non exposed patients |
| Optical coherence tomography | Device | Exposed patients, Non exposed patients |
| Fundus autofluorescence imaging | Device | Exposed patients, Non exposed patients |
Primary outcome
Diagnosis of ARMD based on ophtalmological examination combining color retinography, optical coherence tomography and fundus autofluorescence Imaging
Time frame: Diagnosis of ARMD made during a single consultation lasting about an hour
Risk of ARMD : Ratio between the ARMD prevalence rate in patients with an elevated cumulated dose of L-DOPA and the ARMD prevalence rate in patients with a low cumulated dose of L-DOPA Risk adjusted according to age and sexe
Results and safety
The study was stopped early (reason given: Major difficulties of patient inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
Related trials for Macular Degeneration, Senile
RecruitingPhase 2
A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Geographic Atrophy Secondary to Age-related Macular Degeneration
RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
Not yet recruitingPhase 2/3
A Clinical Trial to Evaluate the Efficacy and Safety of Bevemipretide Ophthalmic Topical Solution in Subjects Who Have Dry Age-Related Macular Degeneration (Dry AMD)
Dry AMD, Age-Related Macular Degeneration (AMD)
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
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 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 Macular Degeneration, Senile, 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 3 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: stopped early, as of the sponsor's last update on 8 Jan 2018. 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 was stopped early (reason given: Major difficulties of patient inclusions). Results are not available in the source record.
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?
Diagnosis of ARMD based on ophtalmological examination combining color retinography, optical coherence tomography and fundus autofluorescence Imaging (time frame: Diagnosis of ARMD made during a single consultation lasting about an hour). 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 8 Jan 2018.