Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
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
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Purpose
This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal LFG316 in patients with advanced age-related macular degeneration.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Age-related Macular Degeneration |
Biological: LFG316 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome 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) ] [ Designated as safety issue: Yes ]
Secondary Outcome 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) ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | November 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LFG316 0.15mg | Biological: LFG316 |
| Experimental: LFG316 0.5mg | Biological: LFG316 |
| Experimental: LFG316 1.5mg | Biological: LFG316 |
| Experimental: LFG316 5mg | Biological: LFG316 |
Eligibility| Ages Eligible for Study: | 55 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255462
Locations
| United States, Arizona | |
| Retinal Consultants of Arizona, | |
| Phoenix, Arizona, United States, 85014 | |
| United States, California | |
| Retina-Vitreous Associates Medical Group, | |
| Beverly Hills, California, United States, 90211 | |
| United States, Florida | |
| National Ophthalmic Research Institute | |
| Fort Myers, Florida, United States, 33912 | |
| Center for Retina and Macular Disease | |
| Winter Haven, Florida, United States, 33880 | |
| United States, Massachusetts | |
| Opthalmic Consultants of Boston | |
| Boston, Massachusetts, United States, 02114 | |
| United States, North Carolina | |
| Charlotte Eye, Ear, Nose and Throat Associates | |
| Charlotte, North Carolina, United States, 28210 | |
| United States, Texas | |
| Texas Retina Associates | |
| Dallas, Texas, United States, 75231 | |
| Retina Consultants of Houston | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01255462 History of Changes |
| Other Study ID Numbers: | CLFG316A2102 |
| Study First Received: | December 6, 2010 |
| Last Updated: | April 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
AMD, ARMD, Age-related Macular Degeneration, Eye Disease, Wet AMD, Neovascular AMD, Choroidal Neovascular Membrane, |
Choroidal Neovascularization, Drusen, Geographic Atrophy, Complement, C5, Antibody |
Additional relevant MeSH terms:
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on June 18, 2013