NCT03415984

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, has shown that Parkinson patients treated with L-DOPA, developed only later an ARMD when compared to the untreated patients. The L-Dopa is an endogenous ligand of the GPR43 receptor (G protein-coupled receptors), 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 estimate the prevalence of ARMD in a sample of Parkinson's Patients followed at Fondation Ophtalmologique Adolphe de Rothschild and to compared it to the prevalence of ARMD of the general population. Furthermore the study aims to explore a possible causal link between L-DOPA treatment and ARMD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 19, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 19, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

January 19, 2018

Last Update Submit

January 31, 2019

Conditions

Parkinson DiseaseAge Related Macular Degeneration

Keywords

Parkinson DiseaseAge Related Macular DegenerationL-DOPA

Outcome Measures

Primary Outcomes (1)

  • Prevalence of ARMD

    Comparison of the percentage of patients with ARMD in both groups (Parkinson's Patients treated or not treated with L-DOPA) : Diagnosis of ARMD by the ophthalmologist is based on 3 exams (Color retinography, Optical coherence tomography and Fundus autofluorescence imaging). In case of any discrepancy between the results of the 3 exams, the final diagnosis of ARMD is based on the Optical coherence tomography.

    baseline

Study Arms (2)

Exposed patients

Patients with Parkinson's disease treated with L-DOPA

Diagnostic Test: Color retinographyDiagnostic Test: Optical coherence tomographyDiagnostic Test: Fundus autofluorescence imaging

Non exposed patients

Patients with Parkinson's disease not treated with L-DOPA

Diagnostic Test: Color retinographyDiagnostic Test: Optical coherence tomographyDiagnostic Test: Fundus autofluorescence imaging

Interventions

Color retinographyDIAGNOSTIC_TEST

Color retinography

Exposed patientsNon exposed patients
Optical coherence tomographyDIAGNOSTIC_TEST

Optical coherence tomography

Exposed patientsNon exposed patients
Fundus autofluorescence imagingDIAGNOSTIC_TEST

Fundus autofluorescence imaging

Exposed patientsNon exposed patients

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Parkinson's disease, treated or not treated with L-DOPA

You may qualify if:

  • Patients aged of 50 years old and more
  • Parkinson's disease

You may not qualify if:

  • Patient under a measure of legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Parkinson DiseaseMacular Degeneration

Interventions

Tomography, Optical CoherenceOptical Imaging

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Martine MAUGET FAYSSE, MD

    Fondation Ophtalmologique A. de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 19, 2018

First Posted

January 30, 2018

Study Start

January 19, 2018

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

FR(1)