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

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Terminated
CT.gov ID
NCT02863640
Collaborator
(none)
13
1
24.1
0.5

Study Details

Study Description

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 A recent epidemiologic study in the US, unpublished yet, has shown that patients treated with the L-DOPA, developed only later an ARMD when compared to the untreated patients.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

Condition or Disease Intervention/Treatment Phase
  • Device: Color retinography
  • Device: Optical coherence tomography
  • Device: Fundus autofluorescence imaging

Study Design

Study Type:
Observational
Actual Enrollment :
13 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Actual Study Start Date :
Dec 14, 2015
Actual Primary Completion Date :
Dec 18, 2017
Actual Study Completion Date :
Dec 18, 2017

Arms and Interventions

Arm Intervention/Treatment
Exposed patients

Patients treated for Parkinson's disease with a cumulative dose of L-DOPA above the 59th percentile of the population

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

Device: Color retinography

Device: Optical coherence tomography

Device: Fundus autofluorescence imaging

Outcome Measures

Primary Outcome Measures

  1. Diagnosis of ARMD based on ophtalmological examination combining color retinography, optical coherence tomography and fundus autofluorescence Imaging [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondation Ophtalmologique A. de Rotchschild Paris France 75019

Sponsors and Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Martine MAUGET FAYSSE, Fondation Ophtalmologique A. de Rothschild

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT02863640
Other Study ID Numbers:
  • MMT_2015_33
First Posted:
Aug 11, 2016
Last Update Posted:
Jan 8, 2018
Last Verified:
Jan 1, 2018
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 8, 2018