Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients

Exclusion Criteria

• •Main criteria for exclusion. The presence of any of the following would make a patient ineligible for enrollment into the study:
• •1. Previous history of allergic response or complications with any dopaminergic agonist drug
• •2. Atypical PD syndromes
• •3. History of stereotactic brain surgery
• •4. Positive hepatitis B (surface antigen) or hepatitis C (antibody)
• •5. Surgery within 180 days of randomization which would negatively impact participation
• •6. Folstein's Mini Mental State Examination (MMSE) score of 24 or less
• •7. History of active epilepsy (seizure) in the past 1 year
• •8. Third degree AV block or sick sinus syndrome
• •9. Congestive heart failure, Class III or IV
• •10. Unstable heart disease such as unstable angina, dysrhythmia, or myocardial infarction in prior 6 months
• •11. Symptomatic orthostatic hypotension
• •12. Clinically significant liver disease or renal disease
• •13. Malignant melanoma or history of previously treated malignant melanoma.
• •14. Prohibited medications taken (including any drug known to have potential retino-toxic effects taken in the prior 12 months; neuroleptics taken within prior 6 months, MAO inhibitors except rasagiline or selegiline taken within prior 3 months, beta-blockers taken to treat Parkinson's disease in the prior 30 days, and Coenzyme Q10 taken within 14 days)
• •15. Albinism/Albinoidism of any degree, type or syndrome
• •16. History of glaucoma with or without treatment
• •17. Inherited or acquired retinopathy such as age-related macular degeneration with visual loss
• •18. Sarcoidosis
• •19. Diabetes mellitus of any degree even if diet or insulin controlled
• •20. Best corrected visual acuity (BCVA) of less than 20/40 by ETDRS
• •21. Refractive error of greater than minus-6 diopters
• •22. Abnormal electroretinogram (ERG)
• •23. Unable to dilate pupils
• •24. History of severe eye trauma that might affect the outcome of the study
• •25. History of psychosis
• •26. Participation in other investigational drug studies or use of investigational drugs within prior 30 days