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Evaluation of the Protective Role of the L-DOPA Against Age Related Macular Degeneration in Parkinson's Patients

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02863640
Acronym
PARM
Enrollment
13
Registered
2016-08-11
Start date
2015-12-14
Completion date
2017-12-18
Last updated
2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration, Senile

Keywords

Senile macular degeneration, Parkinson's disease

Brief 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. A recent epidemiologic study in the US, unpublished yet, has shown that patients treated with the L-DOPA, developed only later an ARMD when compared to the untreated patients.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.

Interventions

DEVICEOptical coherence tomography

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged of 70 years old and more * Parkinson's disease

Exclusion criteria

* Opposition to participate in this trial * Patient under a measure of legal protection * Absence of affiliation to social security or universal health coverage (CMU)

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of ARMD based on ophtalmological examination combining color retinography, optical coherence tomography and fundus autofluorescence ImagingDiagnosis of ARMD made during a single consultation lasting about an hourRisk 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026