AMD-PARK: Prevalence of Age Related Macular Degeneration (ARMD) in Parkinson's Patients and Assesment of the Role of L-DOPA

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Completed
CT.gov ID
NCT03415984
Collaborator
(none)
133
1
11.9
11.2

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, 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.

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

Study Design

Study Type:
Observational
Actual Enrollment :
133 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the Prevalence of Age Related Macular Degeneration (ARMD) in Parkinson's Patients and Assesment of the Role of L-DOPA (AMD-PARK)
Actual Study Start Date :
Jan 19, 2018
Actual Primary Completion Date :
Jan 15, 2019
Actual Study Completion Date :
Jan 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Exposed patients

Patients with Parkinson's disease treated with L-DOPA

Diagnostic Test: Color retinography
Color retinography

Diagnostic Test: Optical coherence tomography
Optical coherence tomography

Diagnostic Test: Fundus autofluorescence imaging
Fundus autofluorescence imaging

Non exposed patients

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

Diagnostic Test: Color retinography
Color retinography

Diagnostic Test: Optical coherence tomography
Optical coherence tomography

Diagnostic Test: Fundus autofluorescence imaging
Fundus autofluorescence imaging

Outcome Measures

Primary Outcome Measures

  1. Prevalence of ARMD [baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients aged of 50 years old and more

  • Parkinson's disease

Exclusion Criteria:
  • Patient under a measure of legal protection

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondation ophtalmologique Adolphe de Rothschild Paris France 75019

Sponsors and Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Martine MAUGET FAYSSE, MD, 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:
NCT03415984
Other Study ID Numbers:
  • MMT_2017_24
First Posted:
Jan 30, 2018
Last Update Posted:
Feb 1, 2019
Last Verified:
Jan 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2019