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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Terminated

Conditions: Macular Degeneration, Senile

Treatments: Device: Fundus autofluorescence imaging; Device: Optical coherence tomography; Device: Color retinography

Study type: Observational

Funder types: NETWORK

Identifiers

NCT02863640

MMT_2015_33

Details and patient eligibility

About

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 A recent epidemiologic study in the US, unpublished yet, has shown that patients treated with the L-DOPA, developed only later an ARMD when compared to the untreated patients.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

Enrollment: 13 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

13 participants in 2 patient groups

Exposed patients

Description:

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

Treatment:

Device: Color retinography

Device: Fundus autofluorescence imaging

Device: Optical coherence tomography

Non exposed patients

Description:

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

Treatment:

Device: Color retinography

Device: Fundus autofluorescence imaging

Device: Optical coherence tomography