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

December 11, 2020 updated by: Novartis Pharmaceuticals

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

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Novartis Investigative Site
    • Florida
      • Winter Haven, Florida, United States, 33880
        • Novartis Investigative Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Day 1 to Day 113 (starting from the day of dosing until the end of the study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 to Day 113
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.
Day 1 to Day 113
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.
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
Time Frame: screening and Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 (for both cohorts).
Blood samples will be collected.
screening and Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 (for both cohorts).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (ESTIMATE)

June 21, 2012

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLFG316A2201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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