Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin α5β1-antagonist is absorbed, broken-down and eliminated from the body when it is given as a single dosage strength by injection into the eye. Repeated dosages will also be given to determine the highest safe dose.
In non-clinical models, JSM6427 can lead to the inhibition and regression of choroidal neovascularization, making α5β1 an attractive target for therapeutic strategies directed at pathological angiogenesis. JSM6427 may also interfere with other key processes in the pathogenesis of AMD, namely inflammation and fibrosis. Further, non-clinical data show that JSM6427 inhibits scarring and inflammation. Thus, JSM6427 may target multiple important pathways in the pathogenesis of neovascular AMD.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JSM6427 | Drug | Weekly intravitreal injections for up to 4 weeks, first dose strength is one dose below the MTD. Dose strength concentrations: 1.5 mg/ml, 3 mg/ml, 7.5 mg/ml 04 15 mg/ml. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability to determine the MTD | 2 weeks after each dose |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the systemic pharmacokinetics of JSM6427 following single and repeat doses by intravitreal injection and to assess exploratory efficacy potential of JSM6427 | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anthony Adamis, MD | Jerini Ophthalmic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States | ||
| Ophthalmic Consultants of Boston |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Boston |
| Massachusetts |
| 02114 |
| United States |
| William Beaumont Research Institute | Royal Oak | Michigan | 40873 | United States |
| Dean McGee Eye Institute | Oklahoma City | Oklahoma | 73120 | United States |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Vitreoretinal Consultants | Houston | Texas | 77030 | United States |
| Valley Retina Institute | McAllen | Texas | 78503 | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C545763 | JSM6427 |
Not provided
Not provided
Not provided