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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01535950
Recruitment Status : Completed
First Posted : February 20, 2012
Last Update Posted : December 19, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : February 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time [ Time Frame: Day 1 to 113 ]
    Number or retreatments with anti-VEGF treatments will be recorded

Secondary Outcome Measures :
  1. The proportion of patients in the study that requires at least one treatment of anti-VEGF medication. [ Time Frame: Day 1 and 113 ]
    Number or retreatments with anti-VEGF treatments will be recorded

  2. Effect of LFG316 on visual acuity [ Time Frame: Day 1 and 113 ]
    Early Treatment Diabetic Retinopathy Study" (ETDRS best corrected visual acuity measured under ESTDRS conditions Number of letters correctly read will be recorded.

  3. 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) ]
    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.

  4. Serum concentrations of total LFG316 versus time [ Time Frame: Days 1, 8, 15, 29, 43, 57, 71, 85 and 113 ]
    Blood samples will be collected

  5. Number of patients with adverse events [ Time Frame: Day 113 ]
    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.

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01535950

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United States, Arizona
Novartis Investigative Site
Tucson, 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
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01535950    
Other Study ID Numbers: CLFG316A2202
First Posted: February 20, 2012    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: March 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Age-related macular degeneration
intravitreal, neovascular
anti-vascular endothelial growth factor
wet AMD
Macular degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases