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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Single subretinal injections, with increasing doses. 9 patients with 3 patients at each dose followed, by 12 patients at maximum tolerated dose.
The University of Iowa
Iowa City, Iowa, United States
Johns Hopkins University Hospital
Baltimore, Maryland, United States
Dr Andreas Lauer - Oregon Health & Science University
Portland, Oregon, United States
The incidence of adverse events
The number and percentage of patients with treatment emergent adverse events.
Time frame: 24 weeks
Change from baseline in subretinal and intraretinal fluid as measured by OCT
The change from baseline in the amount of subretinal and intraretinal fluid measured by Optical Coherence tomography
Time frame: 24 weeks
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