Effect of Levodopa on Human Multifocal Electroretinogram

Phase 4

Completed

• Conditions: Retinal Diseases
• Interventions: Drug: levodopa

• Registration Number: NCT00812760
• Lead Sponsor: Medical University of Vienna

Brief Summary

It is known that dopamine is a functional neuromodulator at several levels of the visual system. Dopamine seems to be involved in the organization of the ganglion cell and the bipolar cell receptive fields and modulation of physiological activity of photoreceptors. There is evidence for the functional significance of dopaminergic modulation of visual sensitivity in humans which confirms the hypothesis that dopamine plays an important role in retinal light adaptation as well as in motion and contrast sensitivity function. The electrophysiological effects of dopamine, various dopamine antagonist and levodopa in animals and humans have been investigated by means of visual evoked potentials and electroretinograms. The multifocal ERG technique, developed by Sutter et al. allows a rapid, simultaneous recording of focal ERGs from multiple retinal locations. Although this technique is relatively new, it has already provided insights into the mechanisms of retinal diseases (e.g. involvement of visual system in Parkinson disease), but until now there is no data on influence of dopaminergic substances on mERG.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Status Verified: 2008-12
• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2008-12-19
• Last Update Submitted: 2008-12-19
• Study First Posted: 2008-12-22
• Last Update Posted: 2008-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Men aged between 19 and 35 years, nonsmokers
• Body mass index between 15th and 85th percentile
• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
• Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
• Normal ophthalmic findings, ametropia < 3 Dpt

Exclusion Criteria

• Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
• Treatment in the previous 3 weeks with any drug
• Symptoms of a clinically relevant illness in the 3 weeks before the first study day
• History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
• History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
• Blood donation during the previous 3 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	levodopa	-

Primary Outcome Measures

Name	Time	Method
Retinal activity (mERG amplitude)	5 measurements on both study days

Secondary Outcome Measures

Name	Time	Method
Retinal activity (mERG latency)	5 measurements on both study days
Dopamine and levodopa plasma levels	on both study days

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria