Clinical trial NCT01624636: Safety and Tolerability of Intravenous LFG316 in Wet Age-related Macular Degeneration (AMD).
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Keywords: AMD
Age-related Macular Degeneration
Wet AMD
Neovascular AMD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-06-21
Enrollment: 1
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: Inclusion Criteria:

- Active choroidal neovascular AMD in at least one eye.

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

Primary outcomes:
measure: Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time
timeFrame: Day 1 to Day 113 (starting from the day of dosing until the end of the study)
measure: Number and percentage of patients with adverse events.
timeFrame: Day 1 to Day 113 (starting from the day of dosing until the end of the study)
Secondary outcomes:
measure: Effect of LFG316 on visual acuity
timeFrame: Day 1 to Day 113
measure: Effect of LFG316 on central retinal thickness, choroidal neovascular membrane area and drusen volume.
timeFrame: Day 1 to Day 113
measure: Serum concentrations of total LFG316 versus time
timeFrame: Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 for both cohorts.
measure: Serum concentration of pharmacodynamic parameters (Weislab and C5) versus time
timeFrame: screening and Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 (for both cohorts).
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Winter Haven
country: United States
facility: Novartis Investigative Site
state: Florida
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: