NCT02863640

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 A recent epidemiologic study in the US, unpublished yet, has shown that patients treated with the L-DOPA, developed only later an ARMD when compared to the untreated patients.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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2017

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

August 3, 2016

Last Update Submit

January 4, 2018

Conditions

Macular Degeneration, Senile

Keywords

Senile macular degenerationParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • 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

    Diagnosis of ARMD made during a single consultation lasting about an hour

Study Arms (2)

Exposed patients

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

Device: Color retinographyDevice: Optical coherence tomographyDevice: 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 retinographyDevice: Optical coherence tomographyDevice: Fundus autofluorescence imaging

Interventions

Color retinographyDEVICE
Exposed patientsNon exposed patients
Optical coherence tomographyDEVICE
Exposed patientsNon exposed patients
Fundus autofluorescence imagingDEVICE
Exposed patientsNon exposed patients

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique A. de Rotchschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Macular Degeneration, Age-Related, 2Macular DegenerationParkinson Disease

Interventions

Tomography, Optical CoherenceOptical Imaging

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Martine MAUGET FAYSSE

    Fondation Ophtalmologique A. de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 11, 2016

Study Start

December 14, 2015

Primary Completion

December 18, 2017

Study Completion

December 18, 2017

Last Updated

January 8, 2018

Record last verified: 2018-01

Locations

FR(1)