Evaluation of the Protective Role of the L-DOPA Against Age Related Macular Degeneration in Parkinson's Patients

NCT ID: NCT02863640

Last Updated: 2018-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-14

Study Completion Date

2017-12-18

Brief Summary

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 A recent epidemiologic study in the US, unpublished yet, has shown that patients treated with the L-DOPA, developed only later an ARMD when compared to the untreated patients.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

Detailed Description

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Conditions

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Macular Degeneration, Senile

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Exposed patients

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

Color retinography

Intervention Type DEVICE

Optical coherence tomography

Intervention Type DEVICE

Fundus autofluorescence imaging

Intervention Type DEVICE

Non exposed patients

Patients treated for Parkinson's disease with a cumulative dose of L-DOPA below the 41th percentile of the population

Color retinography

Intervention Type DEVICE

Optical coherence tomography

Intervention Type DEVICE

Fundus autofluorescence imaging

Intervention Type DEVICE

Interventions

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Color retinography

Intervention Type DEVICE

Optical coherence tomography

Intervention Type DEVICE

Fundus autofluorescence imaging

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martine MAUGET FAYSSE

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique A. de Rothschild

Locations

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Fondation Ophtalmologique A. de Rotchschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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MMT_2015_33

Identifier Type: -

Identifier Source: org_study_id

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