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This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal LFG316 in patients with advanced age-related macular degeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LFG316 0.15mg | Experimental |
| |
| LFG316 0.5mg | Experimental |
| |
| LFG316 1.5mg | Experimental |
| |
| LFG316 5mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LFG316 | Biological |
| ||
| LFG316 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration. | Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the serum pharmacokinetic profile of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration. | Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants of Arizona, | Phoenix | Arizona | 85014 | United States | ||
| Retina-Vitreous Associates Medical Group, |
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|
| LFG316 | Biological |
|
| LFG316 | Biological |
|
| Beverly Hills |
| California |
| 90211 |
| United States |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Opthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Charlotte Eye, Ear, Nose and Throat Associates | Charlotte | North Carolina | 28210 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D005128 | Eye Diseases |
| D020256 | Choroidal Neovascularization |
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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