Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration

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

Official Title
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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

Conditions
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Advanced Age-related Macular Degeneration

Intervention / Treatment
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* Biological: LFG316
* Biological: LFG316
* Biological: LFG316
* Biological: LFG316


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LFG316 0.15mg<br> | Biological: LFG316<br> <br> |
| Experimental: LFG316 0.5mg<br> | Biological: LFG316<br> <br> |
| Experimental: LFG316 1.5mg<br> | Biological: LFG316<br> <br> |
| Experimental: LFG316 5mg<br> | Biological: LFG316<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD,, ARMD,, Age-related Macular Degeneration,, Eye Disease,, Wet AMD,, Neovascular AMD,, Choroidal Neovascular Membrane,, Choroidal Neovascularization,, Drusen,, Geographic Atrophy,, Complement,, C5,, Antibody