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This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of successive intravenous (IV) doses of LFG316 in eligible patients with neovascular age-related macular degeneration (AMD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| LFG316: 10 mg/kg (2 doses in cohort 1) | Experimental |
| |
| LFG316: 20 mg/kg (2 doses in cohort 1, 3 doses in cohort 2). | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| LFG316 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time | Number of retreatments with anti-VEGF treatments will be recorded. | Day 1 to Day 113 (starting from the day of dosing until the end of the study) |
| Number and percentage of patients with adverse events. | Adverse events will be determined based on descriptive analyses of vital signs, ECG evaluation, and clinical safety laboratory evaluations. All abnormalities will be flagged and summary statistics will be provided by treatment and visit/time.Will be tabulated by body system and preferred term with a breakdown by treatment. | Day 1 to Day 113 (starting from the day of dosing until the end of the study) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of LFG316 on visual acuity | "Early Treatment Diabetic Retinopathy Study" (ETDRS best corrected visual acuity measured under ETDRS conditions). Number of letters correctly read will be recorded. | Day 1 to Day 113 |
| Effect of LFG316 on central retinal thickness, choroidal neovascular membrane area and drusen volume. |
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Inclusion Criteria:
- Active choroidal neovascular AMD in at least one eye.
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 |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85014 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CLFG316A2201 from the Novartis Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| LFG316 | Drug |
|
summary statistics will be provided by treatment group, cohort and visit/time. Treatment effect will be assessed by comparison of mean change from baseline to Day 85 of patients who received or did not receive anti-VEGF therapy. |
| Day 1 to Day 113 |
| Serum concentrations of total LFG316 versus time | Blood samples will be collected. | Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 for both cohorts. |
| Serum concentration of pharmacodynamic parameters (Weislab and C5) versus time | Blood samples will be collected. | screening and Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 (for both cohorts). |
| Winter Haven |
| Florida |
| 33880 |
| United States |
| Novartis Investigative Site | Cleveland | Ohio | 44122 | United States |