Neovascular Age-related Macular Degeneration
Conditions
Keywords
AMD, Age-related Macular Degeneration, Wet AMD, Neovascular AMD
Brief summary
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of successive intravenous (IV) doses of LFG316 in eligible patients with neovascular age-related macular degeneration (AMD)
Interventions
DRUGPlacebo
DRUGLFG316
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
\- Active choroidal neovascular AMD in at least one eye.
Exclusion criteria
* Retinal disease other than AMD that, in the investigator's opinion, would interfere with safety or study conduct. * Choroidal neovascularization due to a cause other than AMD. * In the study eye, media opacity that, in the investigator's opinion, would interfere with study conduct. * Any disease or concomitant (or recent) medication expected to cause systemic immunosuppression. * History of meningococcal meningitis in the past 10 years, or any history of recurrent meningitis. * History of hospitalization for pneumococcal pneumonia within the past 3 years. * History of serious systemic infection within the past 12 months. * Any of the following treatments to the study eye within 7 days prior to study drug dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time | Day 1 to Day 113 (starting from the day of dosing until the end of the study) | Number of retreatments with anti-VEGF treatments will be recorded. |
| Number and percentage of patients with adverse events. | Day 1 to Day 113 (starting from the day of dosing until the end of the study) | Adverse events will be determined based on descriptive analyses of vital signs, ECG evaluation, and clinical safety laboratory evaluations. All abnormalities will be flagged and summary statistics will be provided by treatment and visit/time.Will be tabulated by body system and preferred term with a breakdown by treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of LFG316 on visual acuity | Day 1 to Day 113 | Early Treatment Diabetic Retinopathy Study (ETDRS best corrected visual acuity measured under ETDRS conditions). Number of letters correctly read will be recorded. |
| Effect of LFG316 on central retinal thickness, choroidal neovascular membrane area and drusen volume. | Day 1 to Day 113 | summary statistics will be provided by treatment group, cohort and visit/time. Treatment effect will be assessed by comparison of mean change from baseline to Day 85 of patients who received or did not receive anti-VEGF therapy. |
| Serum concentrations of total LFG316 versus time | Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 for both cohorts. | Blood samples will be collected. |
| Serum concentration of pharmacodynamic parameters (Weislab and C5) versus time | screening and Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 (for both cohorts). | Blood samples will be collected. |
Countries
United States
Outcome results
None listed