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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: Placebo; Drug: LFG316

Study type: Interventional

Funder types: Industry

Identifiers

NCT01624636

CLFG316A2201

Details and patient eligibility

About

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)

Enrollment: 1 patient

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

LFG316: 10 mg/kg (2 doses in cohort 1)

Experimental group

Treatment:

Drug: LFG316

Drug: LFG316

LFG316: 20 mg/kg (2 doses in cohort 1, 3 doses in cohort 2).

Experimental group

Treatment:

Drug: LFG316

Drug: LFG316