Open-Label, Pilot Study of TG100801 in Patients With Choroidal Neovascularization Due to AMD
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Change from baseline in central retinal/lesion thickness as measured by OCT at Week 4. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Mean/median change in visual acuity from baseline. Proportion of subjects with loss of > 15 ETDRS letters. Proportion of subjects with loss of > 30 ETDRS letters. Proportion of subjects gaining at least 15 letters. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Eye drop, twice a day, 30 days.
Eye drop, twice a day, 30 days.
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 retinal/lesion thickness, as measured by optical coherence tomography (OCT). The safety of TG100801 in patients with AMD also will be evaluated.
|United States, Arizona|
|Retina Centers, PC|
|Tucson, Arizona, United States, 85704|
|United States, California|
|Retina-Vitreous Associates Medical Group|
|Beverly Hills, California, United States, 90211|
|United States, Florida|
|Center for Retina and Macular Disease|
|Winter Haven, Florida, United States, 33880|
|United States, Massachusetts|
|Ophthalmic Consultants of Boston|
|Boston, Massachusetts, United States, 02114|
|United States, New York|
|Vitreous-Retina-Macula Consultants of New York|
|New York, New York, United States, 10022|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, South Dakota|
|Black Hills Regional Eye Institute|
|Rapid City, South Dakota, United States, 57701|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Peter Kaiser, M.D.||The Cleveland Clinic|