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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01527500
First received: February 2, 2012
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.

  • Freqency of adverse events from single and multiple doses of IVT LFG316 in GA patients [ Time Frame: Day 1 to 85 and to Day 589 ] [ Designated as safety issue: Yes ]
    safety and tolerability of LFG316 from BL through D85 and 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 85 and 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 85 and 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 85 and 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, D141 and D477 ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: January 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LFG316 higher dose
LFG316
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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01527500

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, Arizona
Novartis Investigative Site Recruiting
Phoenix, Arizona, United States, 85014
Novartis Investigative Site Recruiting
Phoenix, Arizona, United States, 85020
Novartis Investigative Site Recruiting
Tuscon, Arizona, United States, 85704-5614
United States, California
Novartis Investigative Site Recruiting
Beverly Hills, California, United States, 90211
Novartis Investigative Site Recruiting
Pasadena, California, United States, 91105-3153
Novartis Investigative Site Recruiting
Sacramento, California, United States, 95841
United States, Colorado
Novartis Investigative Site Recruiting
Colorado Springs, Colorado, United States, 80909-1180
United States, Florida
Novartis Investigative Site Recruiting
Fort Myers, Florida, United States, 33912-7125
Novartis Investigative Site Recruiting
Miami, Florida, United States, 33143
Novartis Investigative Site Recruiting
Winter Haven, Florida, United States, 33880
United States, Georgia
Novartis Investigative Site Recruiting
Atlanta, Georgia, United States, 30342
United States, Kansas
Novartis Investigative Site Recruiting
Leawood, Kansas, United States, 66211
United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Novartis Investigative Site Recruiting
Grand Rapids, Michigan, United States, 49525
Novartis Investigative Site Recruiting
Jackson, Michigan, United States, 49202
United States, North Carolina
Novartis Investigative Site Recruiting
Charlotte, North Carolina, United States, 28210
United States, Ohio
Novartis Investigative Site Recruiting
Beachwood/Cleveland, Ohio, United States, 44122
Novartis Investigative Site Recruiting
Cincinnati, Ohio, United States, 45242
United States, Texas
Novartis Investigative Site Withdrawn
Dallas, Texas, United States, 75231
United States, Washington
Novartis Investigative Site Recruiting
Silverdale, Washington, United States, 98383
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: NCT01527500     History of Changes
Other Study ID Numbers: CLFG316A2203
Study First Received: February 2, 2012
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
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

ClinicalTrials.gov processed this record on September 18, 2014