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

Parkinson Disease Clinical Trial

— AMD-PARK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03415984
• Other study ID #: MMT_2017_24
• Status: Completed
• Start date: January 19, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: January 2019
• 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Patients aged of 50 years old and more

• Parkinson's disease

Exclusion Criteria:

• Patient under a measure of legal protection

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration
• Parkinson Disease

Intervention

Diagnostic Test:
• Color retinography
Color retinography
• Optical coherence tomography
Optical coherence tomography
• Fundus autofluorescence imaging
Fundus autofluorescence imaging

Locations

Country	Name	City	State
France	Fondation ophtalmologique Adolphe de Rothschild	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	Prevalence of ARMD	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.	baseline