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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT01624636

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

0.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Neovascular Age-related Macular Degeneration	Drug: Placebo Drug: LFG316 Drug: LFG316	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Phoenix	Arizona	United States	85014
2	Novartis Investigative Site	Winter Haven	Florida	United States	33880
3	Novartis Investigative Site	Cleveland	Ohio	United States	44122