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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subretinally Injected RetinoStat | Experimental | Subretinally injected RetinoStat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subretinally injected RetinoStat | Drug | Single subretinal injections, with increasing doses. 9 patients with 3 patients at each dose followed, by 12 patients at maximum tolerated dose. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events | The number and percentage of patients with treatment emergent adverse events. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter A Campochiaro, MD | Johns Hopkins University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Iowa | Iowa City | Iowa | 52242-1098 | United States | ||
| Johns Hopkins University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27710144 | Result | Campochiaro PA, Lauer AK, Sohn EH, Mir TA, Naylor S, Anderton MC, Kelleher M, Harrop R, Ellis S, Mitrophanous KA. Lentiviral Vector Gene Transfer of Endostatin/Angiostatin for Macular Degeneration (GEM) Study. Hum Gene Ther. 2017 Jan;28(1):99-111. doi: 10.1089/hum.2016.117. Epub 2016 Sep 26. |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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|
| Baltimore |
| Maryland |
| 21287-9277 |
| United States |
| Dr Andreas Lauer - Oregon Health & Science University | Portland | Oregon | 97239 | United States |