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CompletedNCT03415984AMD-PARKUpdated Feb 1, 2019

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

An observational study in Parkinson Disease and Age Related Macular Degeneration, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-02-01.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
133
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson Disease
  • Age Related Macular Degeneration

Keywords

  • Parkinson Disease
  • Age Related Macular Degeneration
  • L-DOPA
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient under a measure of legal protection
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
133 participants (actual)
Patient registry
No

Groups and cohorts

  • Exposed patients

    Patients with Parkinson's disease treated with L-DOPA

    Diagnostic Test: Color retinography · Diagnostic Test: Optical coherence tomography · Diagnostic Test: Fundus autofluorescence imaging

  • Non exposed patients

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

    Diagnostic Test: Color retinography · Diagnostic Test: Optical coherence tomography · Diagnostic Test: Fundus autofluorescence imaging

Interventions

  • Diagnostic testColor retinography

    Color retinography

  • Diagnostic testOptical coherence tomography

    Optical coherence tomography

  • Diagnostic testFundus autofluorescence imaging

    Fundus autofluorescence imaging

05

What researchers measure

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.

    Time frame: baseline

06

Study locations

1 site
  • Fondation ophtalmologique Adolphe de Rothschild
    Paris, 75019, France
07

Registry details

Key details

Study ID
NCT03415984
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Jan 30, 2018
Start date
Jan 19, 2018
Primary completion
Jan 15, 2019
Completion
Jan 15, 2019
Last update
Feb 1, 2019

Study contacts

Martine MAUGET FAYSSE, MD
principal investigator · Fondation Ophtalmologique A. de Rothschild

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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