Advanced Age-related Macular Degeneration Clinical Trial
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
| Verified date | April 2012 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal LFG316 in patients with advanced age-related macular degeneration.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | September 2011 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 55 Years to 90 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Retina-Vitreous Associates Medical Group, | Beverly Hills | California |
| 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 | National Ophthalmic Research Institute | Fort Myers | Florida |
| United States | Retina Consultants of Houston | Houston | Texas |
| United States | Retinal Consultants of Arizona, | Phoenix | Arizona |
| United States | Center for Retina and Macular Disease | Winter Haven | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the safety and tolerability of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration. | Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study) | Yes | |
| Secondary | To evaluate the serum pharmacokinetic profile of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration. | Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study) | No |