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

Macular Degeneration, Senile Clinical Trial

— PARM  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02863640
• Other study ID #: MMT_2015_33
• Status: Terminated
• Phase: N/A
• First received: August 3, 2016
• Last updated: January 4, 2018
• Start date: December 14, 2015
• Est. completion date: December 18, 2017

Study information

• Verified date: January 2018
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 A recent epidemiologic study in the US, unpublished yet, has shown that patients treated with the L-DOPA, developed only later an ARMD when compared to the untreated patients.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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 18, 2017
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Macular Degeneration
• Macular Degeneration, Senile

Intervention

Device:
• Color retinography

• Optical coherence tomography

• Fundus autofluorescence imaging

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rotchschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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