Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02863640
Recruitment Status : Terminated (Major difficulties of patient inclusions)
First Posted : August 11, 2016
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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 A recent epidemiologic study in the US, unpublished yet, has shown that patients treated with the L-DOPA, developed only later an ARMD when compared to the untreated patients.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
Macular Degeneration, Senile Device: Color retinography Device: Optical coherence tomography Device: Fundus autofluorescence imaging

Layout table for study information
Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Retrospective
Actual Study Start Date : December 14, 2015
Actual Primary Completion Date : December 18, 2017
Actual Study Completion Date : December 18, 2017

Resource links provided by the National Library of Medicine


Group/Cohort 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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863640


Locations
Layout table for location information
France
Fondation Ophtalmologique A. de Rotchschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Layout table for investigator information
Principal Investigator: Martine MAUGET FAYSSE Fondation Ophtalmologique A. de Rothschild

Layout table for additonal information
Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02863640     History of Changes
Other Study ID Numbers: MMT_2015_33
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Senile macular degeneration
Parkinson's disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs