{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T21:03:07Z","timestamp":1740171787640,"version":"3.37.3"},"reference-count":37,"publisher":"Wiley","license":[{"start":{"date-parts":[[2016,1,1]],"date-time":"2016-01-01T00:00:00Z","timestamp":1451606400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim Pharmaceuticals","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Parkinson's Disease"],"published-print":{"date-parts":[[2016]]},"abstract":"<jats:p><jats:italic>Background.<\/jats:italic>Parkinson\u2019s disease (PD) progressively affects dopaminergic neurotransmission and may affect retinal dopaminergic functions and structures.<jats:italic>Objective.<\/jats:italic>This 2-year randomized, open-label, parallel-group, flexible-dose study,<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT00144300\">NCT00144300<\/jats:ext-link>, evaluated ophthalmologic safety profiles of immediate-release (IR) pramipexole and ropinirole in patients with early idiopathic PD with \u22646 months\u2019 prior dopamine agonist exposure and without preexisting major eye disorders.<jats:italic>Methods.<\/jats:italic>Patients received labeled IR regimens of pramipexole (<mml:math xmlns:mml=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M1\"><mml:mi>n<\/mml:mi><mml:mo>=<\/mml:mo><mml:mn fontstyle=\"italic\">121<\/mml:mn><\/mml:math>) or ropinirole (<mml:math xmlns:mml=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M2\"><mml:mi>n<\/mml:mi><mml:mo>=<\/mml:mo><mml:mn fontstyle=\"italic\">125<\/mml:mn><\/mml:math>) 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.<jats:italic>Results.<\/jats:italic>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\u20131.60). Mean changes from baseline in Unified Parkinson\u2019s Disease Rating System parts II+III total scores (pramipexole: 1 year, \u2212<mml:math xmlns:mml=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M3\"><mml:mn fontstyle=\"italic\">4.1<\/mml:mn><mml:mo>\u00b1<\/mml:mo><mml:mn fontstyle=\"italic\">8.9<\/mml:mn><\/mml:math>, and 2 years, \u2212<mml:math xmlns:mml=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M4\"><mml:mn fontstyle=\"italic\">0.7<\/mml:mn><mml:mo>\u00b1<\/mml:mo><mml:mn fontstyle=\"italic\">10.1<\/mml:mn><\/mml:math>, and ropinirole: 1 year, \u2212<mml:math xmlns:mml=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M5\"><mml:mn fontstyle=\"italic\">3.7<\/mml:mn><mml:mo>\u00b1<\/mml:mo><mml:mn fontstyle=\"italic\">8.2<\/mml:mn><\/mml:math>, and 2 years, \u2212<mml:math xmlns:mml=\"http:\/\/www.w3.org\/1998\/Math\/MathML\" id=\"M6\"><mml:mn fontstyle=\"italic\">1.7<\/mml:mn><mml:mo>\u00b1<\/mml:mo><mml:mn fontstyle=\"italic\">10.5<\/mml:mn><\/mml:math>) and Hoehn\u2013Yahr stage distribution showed therapeutic effects on PD symptoms. Safety profiles were consistent with labeling.<jats:italic>Conclusions.<\/jats:italic>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<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT00144300\">NCT00144300<\/jats:ext-link>.<\/jats:p>","DOI":"10.1155\/2016\/8298503","type":"journal-article","created":{"date-parts":[[2016,12,18]],"date-time":"2016-12-18T17:36:38Z","timestamp":1482082598000},"page":"1-14","source":"Crossref","is-referenced-by-count":1,"title":["Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson\u2019s Disease"],"prefix":"10.1155","volume":"2016","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5750-650X","authenticated-orcid":true,"given":"William","family":"Seiple","sequence":"first","affiliation":[{"name":"Lighthouse Guild, Arlene R. Gordon Research Institute, New York, NY, USA"},{"name":"Department of Ophthalmology, NYU School of Medicine, New York, NY, USA"},{"name":"Institute of Vision, Aging in Vision and Action Lab, CNRS-INSERM, University Pierre & Marie Curie, Paris, France"},{"name":"Jesse Brown VA Medical Center, Chicago, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Danna","family":"Jennings","sequence":"additional","affiliation":[{"name":"Institute for Neurodegenerative Disorders, Suite 8B, 60 Temple Street, New Haven, CT 06510, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9643-3510","authenticated-orcid":true,"given":"Richard B.","family":"Rosen","sequence":"additional","affiliation":[{"name":"New York Eye & Ear Infirmary and Icahn School of Medicine of Mount Sinai, 310 East 14th Street, New York, NY 10003, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leona","family":"Borchert","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lee","family":"Canale","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nora","family":"Fagan","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0271-3050","authenticated-orcid":true,"given":"Mark Forrest","family":"Gordon","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT 06877, 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