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This study will assess the safety and efficacy of LFG316 in patients with age related macular degeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LFG316 | Experimental |
| |
| Sham | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LFG316 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time | Number or retreatments with anti-VEGF treatments will be recorded | Day 1 to 113 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients in the study that requires at least one treatment of anti-VEGF medication. | Number or retreatments with anti-VEGF treatments will be recorded | Day 1 and 113 |
| Effect of LFG316 on visual acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Tucson | Arizona | 85704-5614 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CLFG316A2202 from the Novartis Clinical Trials website | View source |
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Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle. |
|
Early Treatment Diabetic Retinopathy Study" (ETDRS best corrected visual acuity measured under ESTDRS conditions Number of letters correctly read will be recorded.
| Day 1 and 113 |
| Effect of LFG316 on central retinal thickness and choroidal neovascular membrane area, and drusen area/volume where applicable | Summary statistics of these variables will be provided by treatment and visit/time. Treatment effect will be assessed by comparison of mean change from baseline to Day 85. | Day 1 , Day 85 and Day 113 (starting from the day of first IVT injection until end of study) |
| Serum concentrations of total LFG316 versus time | Blood samples will be collected | Days 1, 8, 15, 29, 43, 57, 71, 85 and 113 |
| Number of patients with adverse events | Adverse events will be determined based on descriptive analyses of vital signs, electrocardiogram (ECG) evaluation, and clinical safety laboratory evaluations. All abnormalities will be flagged and summary statistics will be provided by treatment and visit/time. | Day 113 |
| Torrance |
| California |
| 90503 |
| United States |
| Novartis Investigative Site | Fort Myers | Florida | 33912-7125 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21237-4350 | United States |
| Novartis Investigative Site | West Columbia | South Carolina | 29169 | United States |
| Novartis Investigative Site | Abilene | Texas | 79606 | United States |
| Novartis Investigative Site | Fort Worth | Texas | 76104 | United States |
| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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