Safety and Tolerability of Intravenous LFG316 in Wet Age-related Macular Degeneration (AMD).
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)
Neovascular Age-related Macular Degeneration
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multiple Dose, Two-cohort Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Intravenous LFG316 in Patients With Neovascular Age-related Macular Degeneration|
- Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time [ Time Frame: Day 1 to Day 113 (starting from the day of dosing until the end of the study) ] [ Designated as safety issue: No ]Number of retreatments with anti-VEGF treatments will be recorded.
- Number and percentage of patients with adverse events. [ Time Frame: Day 1 to Day 113 (starting from the day of dosing until the end of the study) ] [ Designated as safety issue: Yes ]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.
- Effect of LFG316 on visual acuity [ Time Frame: Day 1 to Day 113 ] [ Designated as safety issue: No ]"Early Treatment Diabetic Retinopathy Study" (ETDRS best corrected visual acuity measured under ETDRS conditions). Number of letters correctly read will be recorded.
- Effect of LFG316 on central retinal thickness, choroidal neovascular membrane area and drusen volume. [ Time Frame: Day 1 to Day 113 ] [ Designated as safety issue: No ]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.
- Serum concentrations of total LFG316 versus time [ Time Frame: Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 for both cohorts. ] [ Designated as safety issue: No ]Blood samples will be collected.
- Serum concentration of pharmacodynamic parameters (Weislab and C5) versus time [ Time Frame: screening and Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 (for both cohorts). ] [ Designated as safety issue: No ]Blood samples will be collected.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||Drug: Placebo|
|Experimental: LFG316: 10 mg/kg (2 doses in cohort 1)||Drug: LFG316|
|Experimental: LFG316: 20 mg/kg (2 doses in cohort 1, 3 doses in cohort 2).||Drug: LFG316|
|United States, Arizona|
|Novartis Investigative Site|
|Phoenix, Arizona, United States, 85014|
|United States, Florida|
|Novartis Investigative Site|
|Winter Haven, Florida, United States, 33880|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|