Clinical Studies

NVI-068

The NVI-068 trial was a study of subjects treated with a single dose of 24 Gy epimacular brachytherapy. 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 Ocular Adverse Events – 24 Gy

N=26     Mean follow-up = 23 months (min 3†, max 31)
Event	Frequency
Cataract (>2 LOCS II grade increase from baseline)	55.0% (11/20)*
Subretinal hemorrhage	8.0% (2/26)
Subretinal fibrosis	4.0% (1/26)
Radiation retinopathy	0.0% (1/26)

*Calculated from phakic patients at baseline visit.

†Lost to follow-up