Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509548
Status:
TERMINATED
Last Update Posted:
2010-03-29
First Post:
2007-07-27
Brief Title:
Open-Label Pilot Study of TG100801 in Patients With Choroidal Neovascularization Due to AMD
Sponsor:
TargeGen
Organization:
TargeGen
Study Overview
Official Title:
An Open-Label Randomized Pilot Study of Safety and Preliminary Efficacy of TG100801 in Patients With Choroidal Neovascularization Due to Age-Related Macular Degeneration
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Wet age-related macular degeneration AMD is caused by the formation and growth of abnormal blood vessels angiogenesis in the retina The new blood vessels have fragile walls and can leak fluid into the retina The build-up of fluid edema under the macula can distort vision or cause vision loss TG100801 is a topical eye drop therapy that has been shown to inhibit ocular angiogenesis vascular leak and inflammation in laboratory studies The primary purpose of this pilot study is to evaluate the ability of topical administration of TG100801 to reduce the amount of fluid in the retina in patients with AMD following 30 days of treatment An additional objective is to evaluate the safety of TG100801 in patients with AMD
Detailed Description:
Choroidal neovascularization CNV due to AMD is the leading cause of irreversible severe vision loss in people 55 years and older in the developed world TG100801 is a potent inhibitor of vascular growth endothelial factor VEGF and other kinases that contribute to CNV and macular edema Animal models have demonstrated the ability of TG100801 to inhibit angiogenesis vascular leak and inflammation TG100801 is being developed as a topical eye drop therapy for treatment of CNV due to AMD
The primary objective of this multicenter open-label randomized pilot study is to evaluate the effects of 30 days of dosing with two dose levels of TG100801 on central retinallesion thickness as measured by optical coherence tomography OCT The safety of TG100801 in patients with AMD also will be evaluated
The primary objective of this multicenter open-label randomized pilot study is to evaluate the effects of 30 days of dosing with two dose levels of TG100801 on central retinallesion thickness as measured by optical coherence tomography OCT The safety of TG100801 in patients with AMD also will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None