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

• ClinicalTrials.gov Identifier: NCT01624636
• Recruitment Status: Terminated
• First Posted: June 21, 2012
• Last Update Posted: December 19, 2020
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: May 3, 2012
• First Posted Date: June 21, 2012
• Last Update Posted Date: December 19, 2020
• Study Start Date: December 2012
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 20, 2012)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 11, 2013)

• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: June 20, 2012)

• 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.
• 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 asessed by comaprison of mean change from baseine 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. ]
  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). ]
  Blood samples will be collected.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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)
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Neovascular Age-related Macular Degeneration

Intervention

• Drug: Placebo
• Drug: LFG316

Study Arms

• Placebo Comparator: Placebo
  Intervention: Drug: Placebo
• Experimental: LFG316: 10 mg/kg (2 doses in cohort 1)
  Intervention: Drug: LFG316
• Experimental: LFG316: 20 mg/kg (2 doses in cohort 1, 3 doses in cohort 2).
  Intervention: Drug: LFG316

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 3, 2013): 1
• Original Estimated Enrollment (submitted: June 20, 2012): 59
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States
• Removed Location Countries: Austria, Germany, United Kingdom

Administrative Information

• NCT Number: NCT01624636
• Other Study ID Numbers: CLFG316A2201
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: Same as current
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: March 2016