Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2011

Interventions

  • Biological: LFG316
  • Biological: LFG316
  • Biological: LFG316
  • Biological: LFG316

Arms, Groups and Cohorts

  • Experimental: LFG316 0.15mg
  • Experimental: LFG316 0.5mg
  • Experimental: LFG316 1.5mg
  • Experimental: LFG316 5mg

Clinical Trial Outcome Measures

Primary 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)

Secondary 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)

Participating in This Clinical Trial

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

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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