Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01255462
First received: December 6, 2010
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal LFG316 in patients with advanced age-related macular degeneration.


Condition Intervention Phase
Advanced Age-related Macular Degeneration
Biological: LFG316
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Single Ascending Dose Study to Assess the Safety, Tolerability, and Serum Pharmacokinetics of Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration. [ Time Frame: Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the serum pharmacokinetic profile of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration. [ Time Frame: Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LFG316 0.15mg Biological: LFG316
Experimental: LFG316 0.5mg Biological: LFG316
Experimental: LFG316 1.5mg Biological: LFG316
Experimental: LFG316 5mg Biological: LFG316

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female AMD patients 55 to 90 years old, inclusive. In either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD
  • ETDRS best corrected visual acuity of 60 letters or worse in the study eye.

Exclusion Criteria:

  • Retinal disease other than AMD in study eye which, in the investigator's opinion, may pose a safety risk or interfere with the study.
  • Choroidal neovascularization due to a cause other than AMD.
  • In the study eye, media opacity that interferes with fundus imaging or is likely to require surgery during the study period.
  • Any of the following treatments to the study eye within 14 days prior to dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor; OR likely requirement for one of the above treatments within 14 days of LFG316 administration.
  • Any of the following within 30 days prior to dosing: photodynamic therapy treatment in the study eye; extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye; systemic or topical (ophthalmic) steroid use in the study eye; bacterial keratitis in the study eye; OR intraocular surgery (including cataract surgery) in the fellow eye.
  • Any of the following within 90 days prior to dosing: intraocular surgery (including cataract surgery) in the study eye; OR intravitreal or periocular corticosteroid injection in the study eye.
  • Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 12 weeks prior to the start of study treatment. Clinical trials solely involving over-the-counter vitamins, supplements, or diets will not exclude the patients from study participation.
  • Any medical condition likely to interfere with the patient's participation in the study, or likely to cause serious adverse events during the 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: NCT01255462

Locations
United States, Arizona
Retinal Consultants of Arizona,
Phoenix, Arizona, United States, 85014
United States, California
Retina-Vitreous Associates Medical Group,
Beverly Hills, California, United States, 90211
United States, Florida
National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912
Center for Retina and Macular Disease
Winter Haven, Florida, United States, 33880
United States, Massachusetts
Opthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, North Carolina
Charlotte Eye, Ear, Nose and Throat Associates
Charlotte, North Carolina, United States, 28210
United States, Texas
Texas Retina Associates
Dallas, Texas, United States, 75231
Retina Consultants of Houston
Houston, Texas, United States, 77030
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: NCT01255462     History of Changes
Other Study ID Numbers: CLFG316A2102
Study First Received: December 6, 2010
Last Updated: April 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
AMD,
ARMD,
Age-related Macular Degeneration,
Eye Disease,
Wet AMD,
Neovascular AMD,
Choroidal Neovascular Membrane,
Choroidal Neovascularization,
Drusen,
Geographic Atrophy,
Complement,
C5,
Antibody

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 29, 2014