Safety and Tolerability of Intravenous LFG316 in Wet Age-related Macular Degeneration (AMD).
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
1 other identifier
interventional
1
1 country
3
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2012
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2012
CompletedFirst Posted
Study publicly available on registry
June 21, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedDecember 19, 2020
March 1, 2016
5 months
May 3, 2012
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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 Outcomes (4)
Effect of LFG316 on visual acuity
Day 1 to Day 113
Effect of LFG316 on central retinal thickness, choroidal neovascular membrane area and drusen volume.
Day 1 to Day 113
Serum concentrations of total LFG316 versus time
Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 for both cohorts.
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).
Study Arms (3)
Placebo
PLACEBO COMPARATORLFG316: 10 mg/kg (2 doses in cohort 1)
EXPERIMENTALLFG316: 20 mg/kg (2 doses in cohort 1, 3 doses in cohort 2).
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- \- Active choroidal neovascular AMD in at least one eye.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Novartis Investigative Site
Phoenix, Arizona, 85014, United States
Novartis Investigative Site
Winter Haven, Florida, 33880, United States
Novartis Investigative Site
Cleveland, Ohio, 44122, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2012
First Posted
June 21, 2012
Study Start
December 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
December 19, 2020
Record last verified: 2016-03