Neovascular Age-related Macular Degeneration
Conditions
Interventions
Biological:SCD411 or Eylea (aflibercept), Dosage and administration are subject to those of Eylea, which has already been approved in Japan.
Sponsors
Sakamoto Taiji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age >=50 years. -Active choroidal subfoveal, juxtafoveal, or extrafoveal neovascularization lesions secondary to AMD evidenced by fluorescein angiography (FA) in the study eye at screening and confirmed by the central reading center.
Exclusion criteria
Exclusion criteria: - Any prior ocular (in the study eye and fellow eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins - Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To prove the equivalence of SCD411 as compared to Eylea (aflibercept) in best corrected visual acuity (BCVA) after 8 weeks of treatment among subjects with wet AMD. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To compare the safety and tolerability of SCD411 and aflibercept - To compare the efficacy of SCD411 and aflibercept after 8 weeks and 52 weeks of treatment demonstrated by BCVA, central retinal thickness (CRT), and choroidal neovascularization (CNV) - To compare the immunogenicity of SCD411 and aflibercept by presenting information of the development of anti-SCD411 antibodies. | — |
Countries
Australia, Bulgaria, Czech, Hungary, India, Israel, Japan, Poland, Russia, Slovakia, Spain, The Republic of Korea, US
Contacts
Public ContactPark Youngmi
PPDSNBL K.K.
Outcome results
None listed