NCT02863640|Terminated
Study Stopped
Major difficulties of patient inclusions
Evaluation of the Protective Role of the L-DOPA Against Age Related Macular Degeneration in Parkinson's Patients
PARM
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Sponsor study identifier
observational
13
1 country
1
Study Start
December 14, 2015
Actual (reported)Primary Completion
December 18, 2017
Actual (reported)Study Completion
December 18, 2017
Actual (reported)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 A recent epidemiologic study in the US, unpublished yet, has shown that patients treated with the L-DOPA, developed only later an ARMD when compared to the untreated patients.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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 18, 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 14, 2015
Actual (reported)August 3, 2016
Actual (reported)August 11, 2016
Actual (reported)December 18, 2017
Actual (reported)December 18, 2017
Actual (reported)Diagnosis of ARMD based on ophtalmological examination combining color retinography, optical coherence tomography and fundus autofluorescence Imaging
Risk of ARMD : Ratio between the ARMD prevalence rate in patients with an elevated cumulated dose of L-DOPA and the ARMD prevalence rate in patients with a low cumulated dose of L-DOPA Risk adjusted according to age and sexe
Diagnosis of ARMD made during a single consultation lasting about an hour
Patients treated for Parkinson's disease with a cumulative dose of L-DOPA above the 59th percentile of the population
Patients treated for Parkinson's disease with a cumulative dose of L-DOPA below the 41th percentile of the population
Population of patients followed at Rothschild's Ophthalmologic Foundation for Parkinson's disease. The study is proposed to patients aged of 70 years old and more and with a cumulative dose of L-DOPA above the 59 th percentile of the population or with with a cumulative dose of L-DOPA below the 41th percentile of the population
Fondation Ophtalmologique A. de Rotchschild
Paris, 75019, France
Martine MAUGET FAYSSE
Fondation Ophtalmologique A. de Rothschild
13 participants (actual enrollment reported by the registry).
First Submitted
August 3, 2016
First Posted
August 11, 2016
Study Start
December 14, 2015
Actual (reported)High-resolution Imaging of Tear Film Thickness in Contact Lenses Wearers With Optical Coherence Tomography (OCT). A Pilot Study
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Primary Completion
December 18, 2017
Actual (reported)Study Completion
December 18, 2017
Actual (reported)Last Updated
January 8, 2018
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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