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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01624636
Recruitment Status : Terminated
First Posted : June 21, 2012
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : December 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time [ Time Frame: 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.

  2. Number and percentage of patients with adverse events. [ Time Frame: 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 :
  1. Effect of LFG316 on visual acuity [ Time Frame: 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.

  2. Effect of LFG316 on central retinal thickness, choroidal neovascular membrane area and drusen volume. [ Time Frame: 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.

  3. Serum concentrations of total LFG316 versus time [ Time Frame: Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 for both cohorts. ]
    Blood samples will be collected.

  4. Serum concentration of pharmacodynamic parameters (Weislab and C5) versus time [ Time Frame: screening and Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 (for both cohorts). ]
    Blood samples will be collected.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624636


Locations
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United States, Arizona
Novartis Investigative Site
Phoenix, Arizona, United States, 85014
United States, Florida
Novartis Investigative Site
Winter Haven, Florida, United States, 33880
United States, Ohio
Novartis Investigative Site
Cleveland, Ohio, United States, 44122
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01624636    
Other Study ID Numbers: CLFG316A2201
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: March 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
AMD
Age-related Macular Degeneration
Wet AMD
Neovascular AMD
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases