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Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD)

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ClinicalTrials.gov Identifier: NCT01527500
Recruitment Status : Completed
First Posted : February 7, 2012
Results First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

This study was conducted in two parts; Part A and Part B: Part B was initially planned to include two cohorts. Cohort 2 was cancelled following an interim analysis for efficacy in Part A of the study, and not due to any safety issues or concerns. Cohort 2 is not referred to again and part B cohort 1 is referred to as part B alone in the remainder of the document and is the subject of this report.

Part B was conducted to assess the safety and tolerability of a single intravitreal (IVT) LFG316 10 mg/100 µL injection. There was no efficacy evaluation in Part B. The study employed a multicenter, randomized, sham - controlled, single masked design. Eight patients with advanced AMD were planned to be randomized in a 3:1 ratio to receive a single IVT dose of LFG316 (10 mg/100 µL) or sham injection. Patients assigned to a sham injection were treated the same as those assigned to LFG316, except that the hub of an empty syringe (without needle) was placed against the eye instead of the IVT injection.


Condition or disease Intervention/treatment Phase
Geographic Atrophy Age-related Macular Degeneration Drug: LFG316 Drug: Sham Drug: LFG316 Lower dose Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Sham-control, Proof-of-concept Study of Intravitreal LFG316 in Patients With Geographic Atrophy Associated With Age-related Macular Degeneration
Actual Study Start Date : January 25, 2012
Actual Primary Completion Date : June 24, 2015
Actual Study Completion Date : June 24, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LFG316 higher dose
LFG316 10 mg/100 μL
Drug: LFG316
LFG316 5 mg/50 μL solution for IVT injection,

Sham Comparator: Sham
Sham injection
Drug: Sham
Sham injection (akin to intravitreal injection but without intravitreal needle; no investigational drug given)

Experimental: LFG316 lower dose
LFG316 5 mg/ 50 μL
Drug: LFG316 Lower dose
LFG316 5 mg/50 μL solution for IVT Injection




Primary Outcome Measures :
  1. Part A: Geographic Atrophy (GA) Lesion Growth Measured by Fundus Autofluorescence (FAF) From Baseline to Day 505 [ Time Frame: Day 1 to Day 505 (starting from the day of first intravitreal injection until Day 505) ]
    Geographic atrophy (GA) lesion growth measured by fundus autofluorescence (FAF) from baseline to Day 505.

  2. Part A: Sensitivity Analysis of the Primary End Point: Mixed Effects Model for Repeated Measurements on GA Lesion Growth Measured by Fundus Autoflourescence [ Time Frame: The primary objective was from Day 1 to Day 337, however data was captured to Day 505 as exploratory objective ]
    Number is the Estimated Difference (95% CI) in lesion size.

  3. Part B: Safety and Tolerability of a Single Intravitreal (IVT) Dose of 10 mg/100 μL of LFG316 in Patients With Advanced AMD). [ Time Frame: Day 1 to Day 85 ]
    This primary outcome (for Part B) is reported under the Adverse Events section.


Secondary Outcome Measures :
  1. Part A: Change From Baseline in GA Lesions Growth Measured by Fundus Autofluorescence [ Time Frame: Day 1 to Day 169 and Day 505 (starting from the day of first intravitreal injection until Day 505) ]
    Mean change in GA lesion growth from baseline to Day 169 and Day 505.

  2. Part A: Change in Best Corrected Visual Acuity (BCVA) as Measured by the EDTRS (Early Treatment of Diabetic Retinopathy Study) Scale From Baseline to Days 169, 337 & 505 in Patients Receiving Every 28 Days, Successive IVT Doses of LFG316 Compared to Sham [ Time Frame: Baseline Day 1, Day 169, Day 337 to Day 505 ]
    Part A: Summary of best corrected visual acuity over time, statistical analysis of change in best corrected visual acuity over time Parameter: Visual Acuity (EDTRS letter) BCVA scale is 0-100, worst is 0 and best 100 Eye: STUDY

  3. Part A: Summary of Best Corrected Visual Acuity Over Time, Statistical Analysis of Change in Best Corrected Visual Acuity Over Time Parameter: Visual Acuity (EDTRS Letter) BCVA Scale is 0-100, Worst is 0 and Best 100 Eye: FELLOW [ Time Frame: Baseline Day 1, Day 169, Day 337 to Day 505 ]
    Part A: Summary of best corrected visual acuity over time, statistical analysis of change in best corrected visual acuity over time Parameter: Visual Acuity (EDTRS letter) BCVA scale is 0-100, worst is 0 and best 100 Eye: FELLOW

  4. Part A: Concentrations of Total LFG316 in Blood During the Course of the Study [ Time Frame: Day 1 to Day 559 (starting from the day of first intravitreal injection to day 559) ]

    Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set)

    n=number of participants, h=hours after the last administered dose e.g.; 0.0 means just before dosing. If the mean concentration is 0.00, that means there is no drug in the bloodstream


  5. Part A: Concentrations of Total C5 in Blood During the Course of the Study [ Time Frame: Day 1 to Day 559 (starting from the day of first intravitreal injection to day 559) ]
    Summary statistic of total C5 concentrations n=number of participants, h=scheduled sampling time

  6. Part B: AUC (Area Under the Curve) - Summary Statistics for PK Parameters [ Time Frame: Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85) ]

    Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set)

    n=number of participants, h=scheduled sampling time


  7. Tmax (hr) [ Time Frame: Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85) ]

    PART B: Tmax (Time of Maximum concentration observed)

    This is the highest concentration of drug in the blood that is measured after a dose. Cmax usually happens within a few hours after the dose is taken. The time that Cmax happens is referred to as Tmax. For some antiretroviral drugs, a high Cmax is thought to increase the risk of side effects from the drug.


  8. Part B: Cmax - Summary Statistic for PK Parameters [ Time Frame: Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85) ]
    Summary statistic for Part B of total LFG316 concentrations (pharmacokinetic analysis set) Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose

  9. Part B: Cmax_D - Summary Statistic for PK Parameters [ Time Frame: Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85) ]
    Cmax_D=ng/mL/mg



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of AMD if enrolled in Part B of study
  • Geographic atrophy in at least one eye if enrolled in Part A of study
  • ETDRS best corrected visual acuity of 60 letters or worse (~≤ 20/63)

Exclusion Criteria:

  • Retinal disease other than AMD
  • History of choroidal neovascularization
  • Severe cataract
  • History of infectious uveitis or endophthalmitis
  • Eye surgery in the non-study eye within 30 days prior to study
  • Eye surgery or IVT injection in the study eye within 90 days prior to study
  • Other protocol-defined inclusion/exclusion criteria may apply

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): NCT01527500


Locations
United States, Arizona
Novartis Investigative Site
Phoenix, Arizona, United States, 85014
Novartis Investigative Site
Phoenix, Arizona, United States, 85020
Novartis Investigative Site
Tucson, Arizona, United States, 85704-5614
United States, California
Novartis Investigative Site
Beverly Hills, California, United States, 90211
Novartis Investigative Site
Pasadena, California, United States, 91105-3153
Novartis Investigative Site
Sacramento, California, United States, 95841
United States, Colorado
Novartis Investigative Site
Colorado Springs, Colorado, United States, 80909
United States, Florida
Novartis Investigative Site
Fort Myers, Florida, United States, 33912-7125
Novartis Investigative Site
Miami, Florida, United States, 33143
Novartis Investigative Site
Winter Haven, Florida, United States, 33880
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30342
United States, Kansas
Novartis Investigative Site
Leawood, Kansas, United States, 66211
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02114
United States, Michigan
Novartis Investigative Site
Grand Rapids, Michigan, United States, 49546
Novartis Investigative Site
Jackson, Michigan, United States, 49202
United States, North Carolina
Novartis Investigative Site
Charlotte, North Carolina, United States, 28210
United States, Ohio
Novartis Investigative Site
Cincinnati, Ohio, United States, 45242
Novartis Investigative Site
Cleveland, Ohio, United States, 44122
United States, Washington
Novartis Investigative Site
Silverdale, Washington, United States, 98383
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01527500     History of Changes
Other Study ID Numbers: CLFG316A2203
First Posted: February 7, 2012    Key Record Dates
Results First Posted: July 27, 2018
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Keywords provided by Novartis ( Novartis Pharmaceuticals ):
AMD
Age-related Macular Degeneration
geographic atrophy
GA
Dry AMD
Blindness
Drusen
GA lesion

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical