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

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this first in man study is to examine the safety of an experimental gene transfer agent, RetinoStat, designed to treat neovascular age-related macular degeneration.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oxford BioMedica

Criteria

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.