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

Completed

• Conditions: Age Related Macular Degeneration; Parkinson Disease
• Interventions: Diagnostic Test: Color retinography; Diagnostic Test: Optical coherence tomography; Diagnostic Test: Fundus autofluorescence imaging

• Registration Number: NCT03415984
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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, 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-19
• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-01-30
• Status Verified: 2019-01
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-15
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

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

Exclusion Criteria

• Patient under a measure of legal protection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed patients	Optical coherence tomography	Patients with Parkinson's disease treated with L-DOPA
Non exposed patients	Color retinography	Patients with Parkinson's disease not treated with L-DOPA
Exposed patients	Fundus autofluorescence imaging	Patients with Parkinson's disease treated with L-DOPA
Exposed patients	Color retinography	Patients with Parkinson's disease treated with L-DOPA
Non exposed patients	Fundus autofluorescence imaging	Patients with Parkinson's disease not treated with L-DOPA
Non exposed patients	Optical coherence tomography	Patients with Parkinson's disease not treated with L-DOPA

Primary Outcome Measures

Name	Time	Method
Prevalence of ARMD	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.

Trial Locations

Locations (1)

Fondation ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France