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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 2013

Interventions

  • Drug: LFG316
  • 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.

Arms, Groups and Cohorts

  • Experimental: LFG316
  • Sham Comparator: Sham

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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.
  • 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.
  • 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
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

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