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Completed

NCT Number: NCT03415984

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient under a measure of legal protection

Treatment and study plan

Color retinography

Diagnostic Test

Color retinography

Optical coherence tomography

Diagnostic Test

Optical coherence tomography

Fundus autofluorescence imaging

Diagnostic Test

Fundus autofluorescence imaging

Primary outcomes

  1. Prevalence of ARMD

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study 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)

Acronym: AMD-PARK

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2018
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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