Phase I Dose Escalation Safety Study of RetinoStat in Advanced Age-Related Macular Degeneration (AMD)

There are two parts to the study. A dose-escalation phase looking at three doses of
RetinoStat starting with the lowest dose, three patients will be recruited at each dose
level. The escalation phase will be followed by a dose confirmation phase where the highest
dose that is safe and well tolerated will be examined in 9 patients.

Inclusion Criteria:

- Clinical diagnosis of AMD with active CNV that shows evidence of leakage.

- BCVA less than or equal to 20/200 in the study eye for dose escalation phase.

- BCVA less than or equal to 20/80 in the study eye for maximum tolerated dose phase.

Exclusion Criteria:

- Significant ocular abnormalities that prevent retinal assessment.

- Treatment with steroids within three months of screening.

- Treatment with anti-VEGF therapy to either eye within one month of screening.

- Clinically significant intercurrent illnesses, laboratory, ECG or chest XRay
abnormalities.