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

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
LFG316
LFG316
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring AMD, Age-related Macular Degeneration, Wet AMD, Neovascular AMD

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

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

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

Arm Description

Outcomes

Primary Outcome Measures

Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time
Number of retreatments with anti-VEGF treatments will be recorded.
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.

Secondary Outcome Measures

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.
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.
Serum concentrations of total LFG316 versus time
Blood samples will be collected.
Serum concentration of pharmacodynamic parameters (Weislab and C5) versus time
Blood samples will be collected.

Full Information

First Posted
May 3, 2012
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01624636
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Study Start Date
December 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
Keywords
AMD, Age-related Macular Degeneration, Wet AMD, Neovascular AMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
LFG316: 10 mg/kg (2 doses in cohort 1)
Arm Type
Experimental
Arm Title
LFG316: 20 mg/kg (2 doses in cohort 1, 3 doses in cohort 2).
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
LFG316
Intervention Type
Drug
Intervention Name(s)
LFG316
Primary Outcome Measure Information:
Title
Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time
Description
Number of retreatments with anti-VEGF treatments will be recorded.
Time Frame
Day 1 to Day 113 (starting from the day of dosing until the end of the study)
Title
Number and percentage of patients with adverse events.
Description
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.
Time Frame
Day 1 to Day 113 (starting from the day of dosing until the end of the study)
Secondary Outcome Measure Information:
Title
Effect of LFG316 on visual acuity
Description
"Early Treatment Diabetic Retinopathy Study" (ETDRS best corrected visual acuity measured under ETDRS conditions). Number of letters correctly read will be recorded.
Time Frame
Day 1 to Day 113
Title
Effect of LFG316 on central retinal thickness, choroidal neovascular membrane area and drusen volume.
Description
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.
Time Frame
Day 1 to Day 113
Title
Serum concentrations of total LFG316 versus time
Description
Blood samples will be collected.
Time Frame
Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 for both cohorts.
Title
Serum concentration of pharmacodynamic parameters (Weislab and C5) versus time
Description
Blood samples will be collected.
Time Frame
screening and Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 (for both cohorts).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Novartis Investigative Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Novartis Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=11763
Description
Results for CLFG316A2201 from the Novartis Clinical Trials website

Learn more about this trial

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

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