Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Ocular Safety of SCH 530348 in Subjects Participating in the Schering-Plough P04737 Study (TRA^SM-Secondary Prevention Ocular Safety Study)

This study is designed to evaluate the long-term ocular safety of SCH 530348 (vorapaxar) in participants with established atherosclerotic disease who are enrolled into the TRA 2°P - TIMI 50 Study (P04737) (NCT00526474).

Inclusion Criteria:

• Evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems

Exclusion Criteria:

• The study will include participants who meet none of the exclusion criteria for the parent protocol (P04737) and also the following:

  • history or evidence of age-related macular degeneration on baseline evaluation
  • history of diabetic macular edema, or evidence of treated diabetic retinopathy on baseline evaluation
  • history or evidence of other retinal diseases, including retinal injury, on baseline evaluation
  • history or evidence of retinal surgery, including laser photocoagulation, on baseline evaluation
  • history or evidence of glaucoma on baseline evaluation
  • history or evidence of high intraocular pressure of >22 mm Hg on baseline evaluation
  • evidence of center foveal thickness of >190 µm on baseline OCT examination
  • presence of vacuoles in the retina on baseline OCT