Safety Criteria for Adjusting or Stopping Doses Sample Clauses

Safety Criteria for Adjusting or Stopping Doses. If more than one of the following dose limiting toxicities is observed in any one cohort, planned doses may be adjusted or stopped by the Safety Review Team. • Visual acuity loss from Baseline Visit defined as: • Loss of best corrected visual activity (BCVA) of 15 or more letters OR • Progression to no light perception vision (NLP) not due to injection procedure • Clinically significant inflammation defined as: • Anterior chamber cell and/or flare of grade 2+ or more OR • >3+ vitreous haze as measured by the National Eye Institute Grading Scheme (Xxxxxxxxxxx et al., 1985) OR • Sterile endophthalmitis (including the presence of hypopyon)‌ • Severe Intraocular Pressure (IOP) elevation as measured by tonometry, on two separate exams, at least one day apart, excluding day of injection (despite pharmaceutical intervention): • >30 mmHg OR • Increase of > 15 mmHg from baseline If any of the following adverse events (AEs) occur in any one subject in any cohort, planned doses will be adjusted by treating additional subjects at the same or lower dose level (the occurrence of a second adverse event in either the same or different subjects in one cohort will qualify for study termination, Section 4.5): • Retinal non-perfusion/vascular occlusion of the study eye • Retinal vasculitis • Retinitis • 2+ disc edema • > 2 quadrants of retinal hemorrhage If there is insufficient safety information in a given cohort at any time, the Safety Review Team may determine to treat additional subjects within that cohort before moving to the next cohort.
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