NCT Number: NCT01255462
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.
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Notify MeKey information
Conditions
Age range
55 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Retinal Consultants of Arizona,, Phoenix, Arizona, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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 outcomes
-
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)
Sponsors and collaborators
Lead sponsor
Novartis Pharmaceuticals
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2010
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Dec 7, 2010
- Registry last updated
- May 1, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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