Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: February 2, 2012
Last updated: January 13, 2015
Last verified: January 2015

The amendment is designed to test the safety and efficacy of lower and higher doses of Intravitreal (IVT) LFG316 using single and 18 successive monthly injections in patients with geographic atrophy (GA). The study will also provide information on the safety, tolerability, serum concentrations and pharmacodynamics of single and multiple IVT doses of LFG316.

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

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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Growth of GA lesions as measured by fundus autofluorescence (FAF) from baseline to month 12 [ Time Frame: Day 1 to Day 337 (starting from the day of first intravitreal injection until the end of the study) ] [ Designated as safety issue: No ]
    FAF is a non-invasive imaging procedure that measure the size of the GA lesions.

  • Frequency of adverse events from single and multiple doses of IVT LFG316 in GA patients [ Time Frame: Day 1 to Day 589 ] [ Designated as safety issue: Yes ]
    safety and tolerability of LFG316 from BL through D589

Secondary Outcome Measures:
  • Frequency of adverse events from 12 successive, every 4 weeks, IVT doses of LFG316 in GA patients [ Time Frame: Day 1 to Day 337 (starting from the day of first intravitreal injection until the end of the study) ] [ Designated as safety issue: Yes ]
  • Changes in best corrected visual acuity (BCVA) as measured on the ETDRS (Early Treatment in Diabetic Retinopathy Study) scale from 12 successive, every 4 weeks, IVT doses of LFG316 [ Time Frame: Day 1 to Day 337 (starting from the day of first intravitreal injection until the end of the study) ] [ Designated as safety issue: No ]
  • Concentrations of total LFG316 and total C5 in the blood during the course of the study from single dose and 12 successive, every 4 weeks, IVT doses of LFG316 (lower and higher dose) [ Time Frame: Day 1 to Day 337 (starting from the day of first intravitreal injection until the end of the study) ] [ Designated as safety issue: No ]
  • Efficacy of 6 and 18 successive, every 4 weeks, IVT doses of LFG316 on GA lesion [ Time Frame: D1, D169 and D477 ] [ Designated as safety issue: No ]

Enrollment: 158
Study Start Date: January 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LFG316 higher dose
LFG316 higher dose
Drug: LFG316
LFG316 20 mg/0.2 mL solution (in 2 mL vial) 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 lower dose
Drug: LFG316 Lower dose
LFG316 20 mg/0.2 mL solution for IVT Injection


Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of AMD
  • Geographic atrophy in at least one eye
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01527500

United States, Arizona
Novartis Investigative Site
Phoenix, Arizona, United States, 85014
Novartis Investigative Site
Phoenix, Arizona, United States, 85020
Novartis Investigative Site
Tuscon, 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, 80909-1180
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, 49525
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
Beachwood/Cleveland, Ohio, United States, 44122
Novartis Investigative Site
Cincinnati, Ohio, United States, 45242
United States, Washington
Novartis Investigative Site
Silverdale, Washington, United States, 98383
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT01527500     History of Changes
Other Study ID Numbers: CLFG316A2203
Study First Received: February 2, 2012
Last Updated: January 13, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Age-related Macular Degeneration
geographic atrophy
GA lesion

Additional relevant MeSH terms:
Geographic Atrophy
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases processed this record on March 01, 2015