Clinical Studies

NVI-111

The NVI-111 trial was a study of subjects treated with a single dose of 24 Gy epimacular brachytherapy and two injections of bevacizumab (1.25 mg). Subjects received one injection prior to surgery (10±4 days) or at the time of surgery and the second injection at Month 1. Subjects were re-treated with bevacizumab per the investigator’s discretion at follow-up visits. Safety parameters evaluated included incidence and severity of ocular adverse events identified by slit lamp and indirect ophthalmoscopic examination, fluorescein angiography, and optical coherence tomography.

Investigator-determined adverse events

Event	Frequency
Cataract (>2 LOCS II grade increase from baseline)	25.0% (6/24)*
Subretinal fibrosis	5.8% (2/34)
Epimacular membrane	2.9% (1/34)
Retinal tear	2.9% (1/34)
Subretinal hemorrhage	2.9% (1/34)

*Calculated from phakic patients at baseline visit.