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Parkinson’s Disease
Volume 2016 (2016), Article ID 8298503, 14 pages
http://dx.doi.org/10.1155/2016/8298503
Clinical Study

Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson’s Disease

1Lighthouse Guild, Arlene R. Gordon Research Institute, New York, NY, USA
2Department of Ophthalmology, NYU School of Medicine, New York, NY, USA
3Institute of Vision, Aging in Vision and Action Lab, CNRS-INSERM, University Pierre & Marie Curie, Paris, France
4Jesse Brown VA Medical Center, Chicago, IL, USA
5Institute for Neurodegenerative Disorders, Suite 8B, 60 Temple Street, New Haven, CT 06510, USA
6New York Eye & Ear Infirmary and Icahn School of Medicine of Mount Sinai, 310 East 14th Street, New York, NY 10003, USA
7Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA

Received 1 July 2016; Revised 6 October 2016; Accepted 31 October 2016

Academic Editor: Hélio Teive

Copyright © 2016 William Seiple et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background. Parkinson’s disease (PD) progressively affects dopaminergic neurotransmission and may affect retinal dopaminergic functions and structures. Objective. This 2-year randomized, open-label, parallel-group, flexible-dose study, NCT00144300, evaluated ophthalmologic safety profiles of immediate-release (IR) pramipexole and ropinirole in patients with early idiopathic PD with ≤6 months’ prior dopamine agonist exposure and without preexisting major eye disorders. Methods. Patients received labeled IR regimens of pramipexole () or ropinirole () for 2 years. Comprehensive ophthalmologic assessments (COA) included corrected acuity, Roth 28-color test, slit-lamp biomicroscopy, intraocular pressure, computerized visual field test, fundus photography, and electroretinography. Results. At baseline, we observed retinal pigmentary epithelium (RPE) hypopigmentation not previously reported in PD patients. The estimated relative risk of 2-year COA worsening with pramipexole versus ropinirole was 1.07 (95% CI: 0.71–1.60). Mean changes from baseline in Unified Parkinson’s Disease Rating System parts II+III total scores (pramipexole: 1 year, −, and 2 years, −, and ropinirole: 1 year, −, and 2 years, −) and Hoehn–Yahr stage distribution showed therapeutic effects on PD symptoms. Safety profiles were consistent with labeling. Conclusions. The risk of retinal deterioration did not differ in early idiopathic PD patients receiving pramipexole versus ropinirole. RPE hypopigmentation at baseline was not previously reported in this population. This trial is registered with NCT00144300.