Phase I Dose Escalation Safety Study of RetinoStat in Advanced Age-Related Macular Degeneration (AMD)
This trial is active, not recruiting.
|Condition||age related macular degeneration|
|Treatment||3 dose cohorts gene therapy|
|Start date||February 2011|
|End date||September 2014|
|Trial size||21 participants|
|Trial identifier||NCT01301443, RS1/001/10|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Iowa City, IA||The University of Iowa||no longer recruiting|
|Baltimore, MD||Johns Hopkins University Hospital||no longer recruiting|
|Portland, OR||Dr Andreas Lauer - Oregon Health & Science University||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Dose escalation of subretinally injected RetinoStat
The incidence of adverse events
time frame: 24 weeks
Change from baseline in subretinal and intraretinal fluid as measured by OCT
time frame: 24 weeks
Male or female participants at least 50 years old.
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.
|Official title||A Phase I Dose Escalation Safety Study of Subretinally Injected RetinoStat, a Lentiviral Vector Expressing Endostatin and Angiostatin, in Patients With Advanced Neovascular Age-Related Macular Degeneration|
|Principal investigator||Peter A Campochiaro, MD|
|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.|
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