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

Neovascular Age-related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01624636
• Other study ID #: CLFG316A2201
• Status: Terminated
• Phase: Phase 2
• Start date: December 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Placebo

• LFG316

• LFG316

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time	Number of retreatments with anti-VEGF treatments will be recorded.	Day 1 to Day 113 (starting from the day of dosing until the end of the study)
Primary	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.	Day 1 to Day 113 (starting from the day of dosing until the end of the study)
Secondary	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.	Day 1 to Day 113
Secondary	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.	Day 1 to Day 113
Secondary	Serum concentrations of total LFG316 versus time	Blood samples will be collected.	Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 for both cohorts.
Secondary	Serum concentration of pharmacodynamic parameters (Weislab and C5) versus time	Blood samples will be collected.	screening and Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 (for both cohorts).

External Links

•   Results for CLFG316A2201 from the Novartis Clinical Trials website