Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration

Completed · Phase 1

Conditions studied: Advanced Age-related Macular Degeneration

In brief

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

Key facts

Study ID

NCT01255462

Run by

Novartis Pharmaceuticals

People needed

24

Starts

2010-11-01

Expected to finish

2011-09-01

Last updated by the study team

2012-05-01

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Retinal Consultants of Arizona, — Phoenix, Arizona, United States
• Retina-Vitreous Associates Medical Group, — Beverly Hills, California, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Center for Retina and Macular Disease — Winter Haven, Florida, United States
• Opthalmic Consultants of Boston — Boston, Massachusetts, United States
• Charlotte Eye, Ear, Nose and Throat Associates — Charlotte, North Carolina, United States
• Texas Retina Associates — Dallas, Texas, United States
• Retina Consultants of Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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