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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

December 6, 2010
April 30, 2012
November 2010
September 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01255462 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Age-related Macular Degeneration
Biological: LFG316
  • Experimental: LFG316 0.15mg
    Intervention: Biological: LFG316
  • Experimental: LFG316 0.5mg
    Intervention: Biological: LFG316
  • Experimental: LFG316 1.5mg
    Intervention: Biological: LFG316
  • Experimental: LFG316 5mg
    Intervention: Biological: LFG316
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2011
September 2011   (final data collection date for primary outcome measure)

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

Both
55 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01255462
CLFG316A2102
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP