- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01255462
Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration
April 30, 2012 updated by: Novartis Pharmaceuticals
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85014
- Retinal Consultants of Arizona,
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California
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Beverly Hills, California, United States, 90211
- Retina-Vitreous Associates Medical Group,
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Florida
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Fort Myers, Florida, United States, 33912
- National Ophthalmic Research Institute
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Winter Haven, Florida, United States, 33880
- Center for Retina and Macular Disease
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Opthalmic Consultants of Boston
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North Carolina
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Charlotte, North Carolina, United States, 28210
- Charlotte Eye, Ear, Nose and Throat Associates
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Texas
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Dallas, Texas, United States, 75231
- Texas Retina Associates
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Houston, Texas, United States, 77030
- Retina Consultants of Houston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: LFG316 0.15mg
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Experimental: LFG316 0.5mg
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Experimental: LFG316 1.5mg
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Experimental: LFG316 5mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
December 6, 2010
First Submitted That Met QC Criteria
December 6, 2010
First Posted (Estimate)
December 7, 2010
Study Record Updates
Last Update Posted (Estimate)
May 1, 2012
Last Update Submitted That Met QC Criteria
April 30, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLFG316A2102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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