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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01624636
First received: May 3, 2012
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Neovascular Age-related Macular Degeneration
 Drug: Placebo
Drug: LFG316
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Number of retreatments with anti-VEGF treatments will be recorded.

  • 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) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 1 to Day 113 ] [ Designated as safety issue: No ]
    "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. [ Time Frame: Day 1 to Day 113 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 for both cohorts. ] [ Designated as safety issue: No ]
    Blood samples will be collected.

  • 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). ] [ Designated as safety issue: No ]
    Blood samples will be collected.


Enrollment: 13
Study Start Date: December 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624636

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01624636     History of Changes
Other Study ID Numbers: CLFG316A2201
Study First Received: May 3, 2012
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
AMD
Age-related Macular Degeneration
Wet AMD
Neovascular AMD

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013