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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Winter Haven, Florida, United States
Novartis Investigative Site
Cleveland, Ohio, United States
Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time
Number of retreatments with anti-VEGF treatments will be recorded.
Time frame: 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.
Time frame: Day 1 to Day 113 (starting from the day of dosing until the end of the study)
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.
Time frame: Day 1 to Day 113
Effect of LFG316 on central retinal thickness, choroidal neovascular membrane area and drusen volume.
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.
Time frame: Day 1 to Day 113
Serum concentrations of total LFG316 versus time
Blood samples will be collected.
Time frame: 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.
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Time frame: screening and Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 (for both cohorts).