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

Oxford BioMedica

Status and phase

Completed

Phase 1

Conditions

Age Related Macular Degeneration

Treatments

Drug: Subretinally injected RetinoStat

Study type

Interventional

Funder types

Industry

Identifiers

NCT01301443

RS1/001/10

Details and patient eligibility

About

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.

Full description

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.

Enrollment

21 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.