Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)

Study Overview
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Brief Summary
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This study will assess the safety and efficacy of LFG316 in patients with age related macular degeneration.

Official Title
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A Multicenter, Randomized, Sham-controlled, Repeat-dose Study to Assess the Safety, Tolerability, Serum Pharmacokinetics, and Efficacy of Intravitreal LFG316 in Patients With Neovascular Age-related Macular Degeneration

Conditions
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Neovascular Age-elated Macular Degeneration (Wet AMD), Exudative Macular Degeneration

Intervention / Treatment
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* Drug: LFG316
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Best corrected visual acuity (ETDRS scale) of 60 letters or less in the study eye. An active choroidal neovascular membrane attributable to neovascular AMD in at least one eye. History of treatment (at any time) with at least 3 doses of anti-VEGF therapy in the study eye. Exclusion Criteria: History of recurrent non-response to anti-VEGF therapy in the study eye. In the study eye, retinal disease other than AMD (benign conditions of the vitreous and peripheral retina are not exclusionary). Choroidal neovascularization due to a cause other than AMD. In the study eye, media opacity that, in the investigator's opinion, could interfere with conduct of the study. History of infectious uveitis or endophthalmitis in either eye. Any of the following treatments to the study eye within 28 days prior to dosing: ranibizumab, bevacizumab, pegaptanib or other VEGF inhibitor. Any of the following within 90 days prior to dosing: photodynamic therapy or laser photocoagulation in the study eye; intravitreal steroid in the study eye; or intraocular surgery (including cataract surgery) in the study eye

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LFG316<br> | Drug: LFG316<br> <br> |
| Sham Comparator: Sham<br> | Drug: Placebo<br>* Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time | Number or retreatments with anti-VEGF treatments will be recorded | Day 1 to 113 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients in the study that requires at least one treatment of anti-VEGF medication. | Number or retreatments with anti-VEGF treatments will be recorded | Day 1 and 113 | 
| Effect of LFG316 on visual acuity | Early Treatment Diabetic Retinopathy Study (ETDRS best corrected visual acuity measured under ESTDRS conditions Number of letters correctly read will be recorded. | Day 1 and 113 | 
| Effect of LFG316 on central retinal thickness and choroidal neovascular membrane area, and drusen area/volume where applicable | Summary statistics of these variables will be provided by treatment and visit/time. Treatment effect will be assessed by comparison of mean change from baseline to Day 85. | Day 1 , Day 85 and Day 113 (starting from the day of first IVT injection until end of study) | 
| Serum concentrations of total LFG316 versus time | Blood samples will be collected | Days 1, 8, 15, 29, 43, 57, 71, 85 and 113 | 
| Number of patients with adverse events | Adverse events will be determined based on descriptive analyses of vital signs, electrocardiogram (ECG) evaluation, and clinical safety laboratory evaluations. All abnormalities will be flagged and summary statistics will be provided by treatment and visit/time. | Day 113 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age-related macular degeneration, intravitreal, neovascular, anti-vascular endothelial growth factor, wet AMD, Age-related, Macular degeneration, Intravitreal, Neovascular