Safety and Tolerability of Intravenous LFG316 in Wet Age-related Macular Degeneration (AMD).

Phase 2

Terminated

Brief Summary: 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)

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Retinal disease other than AMD that, in the investigator's opinion, would interfere with safety or study conduct.
Choroidal neovascularization due to a cause other than AMD.
In the study eye, media opacity that, in the investigator's opinion, would interfere with study conduct.
Any disease or concomitant (or recent) medication expected to cause systemic immunosuppression.
History of meningococcal meningitis in the past 10 years, or any history of recurrent meningitis.
History of hospitalization for pneumococcal pneumonia within the past 3 years.
History of serious systemic infection within the past 12 months.
Any of the following treatments to the study eye within 7 days prior to study drug dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor.

Other protocol-defined inclusion/exclusion criteria may apply

Arm && Interventions

Group	Intervention	Description
LFG316: 10 mg/kg (2 doses in cohort 1)	LFG316	-
LFG316: 20 mg/kg (2 doses in cohort 1, 3 doses in cohort 2).	LFG316	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time	Day 1 to Day 113 (starting from the day of dosing until the end of the study)	Number of retreatments with anti-VEGF treatments will be recorded.
Number and percentage of patients with adverse events.	Day 1 to Day 113 (starting from the day of dosing until the end of the study)	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.

Secondary Outcome Measures

Name	Time	Method
Effect of LFG316 on visual acuity	Day 1 to Day 113	"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.	Day 1 to Day 113	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	Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 for both cohorts.	Blood samples will be collected.
Serum concentration of pharmacodynamic parameters (Weislab and C5) versus time	screening and Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 (for both cohorts).	Blood samples will be collected.