Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01535950
First received: February 10, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

This study will assess the safety and efficacy of LFG316 in patients with age related macular degeneration.


Condition Intervention Phase
Neovascular Age-elated Macular Degeneration (Wet AMD)
Exudative Macular Degeneration
Drug: LFG316
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Sham-controlled, Repeat-dose Study to Assess the Safety, Tolerability, Serum Pharmacokinetics, and Efficacy of Intravitreal LFG316 in Patients With Neovascular Age-related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time [ Time Frame: Day 1 to 113 ] [ Designated as safety issue: No ]
    Number or retreatments with anti-VEGF treatments will be recorded


Secondary Outcome Measures:
  • The proportion of patients in the study that requires at least one treatment of anti-VEGF medication. [ Time Frame: Day 1 and 113 ] [ Designated as safety issue: No ]
    Number or retreatments with anti-VEGF treatments will be recorded

  • Effect of LFG316 on visual acuity [ Time Frame: Day 1 and 113 ] [ Designated as safety issue: No ]
    Early Treatment Diabetic Retinopathy Study" (ETDRS best corrected visual acuity measured under ESTDRS conditions Number of letters correctly read will be recorded.

  • Effect of LFG316 on central retinal thickness and choroidal neovascular membrane area, and drusen area/volume where applicable [ Time Frame: Day 1 , Day 85 and Day 113 (starting from the day of first IVT injection until end of study) ] [ Designated as safety issue: No ]
    Summary statistics of these variables will be provided by treatment and visit/time. Treatment effect will be assessed by comparison of mean change from baseline to Day 85.

  • Serum concentrations of total LFG316 versus time [ Time Frame: Days 1, 8, 15, 29, 43, 57, 71, 85 and 113 ] [ Designated as safety issue: No ]
    Blood samples will be collected

  • Number of patients with adverse events [ Time Frame: Day 113 ] [ Designated as safety issue: Yes ]
    Adverse events will be determined based on descriptive analyses of vital signs, electrocardiogram (ECG) evaluation, and clinical safety laboratory evaluations. All abnormalities will be flagged and summary statistics will be provided by treatment and visit/time.


Enrollment: 43
Study Start Date: February 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LFG316 Drug: LFG316
Sham Comparator: Sham Drug: Placebo
Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle.

  Eligibility

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

Inclusion Criteria:

  • Best corrected visual acuity (ETDRS scale) of 60 letters or less in the study eye.
  • An active choroidal neovascular membrane attributable to neovascular AMD in at least one eye.
  • History of treatment (at any time) with at least 3 doses of anti-VEGF therapy in the study eye.

Exclusion Criteria:

  • History of recurrent non-response to anti-VEGF therapy in the study eye.
  • In the study eye, retinal disease other than AMD (benign conditions of the vitreous and peripheral retina are not exclusionary).
  • Choroidal neovascularization due to a cause other than AMD.
  • In the study eye, media opacity that, in the investigator's opinion, could interfere with conduct of the study.
  • History of infectious uveitis or endophthalmitis in either eye.
  • Any of the following treatments to the study eye within 28 days prior to dosing: ranibizumab, bevacizumab, pegaptanib or other VEGF inhibitor.
  • Any of the following within 90 days prior to dosing: photodynamic therapy or laser photocoagulation in the study eye; intravitreal steroid in the study eye; or intraocular surgery (including cataract surgery) in the study eye
  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: NCT01535950

Locations
United States, Arizona
Novartis Investigative Site
Tuscon, Arizona, United States, 85704-5614
United States, California
Novartis Investigative Site
Torrance, California, United States, 90503
United States, Florida
Novartis Investigative Site
Fort Myers, Florida, United States, 33912-7125
United States, Maryland
Novartis Investigative Site
Baltimore, Maryland, United States, 21237-4350
United States, South Carolina
Novartis Investigative Site
West Columbia, South Carolina, United States, 29169
United States, Texas
Novartis Investigative Site
Abilene, Texas, United States, 79606
Novartis Investigative Site
Forth Worth, Texas, United States, 76104
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: NCT01535950     History of Changes
Other Study ID Numbers: CLFG316A2202
Study First Received: February 10, 2012
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Age-related macular degeneration
intravitreal, neovascular
anti-vascular endothelial growth factor
wet AMD
Age-related
Macular degeneration
Intravitreal
Neovascular
Anti-vascular endothelial growth factor
Wet AMD

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014