A Phase III Study of SCD411 in Subjects with Neovascular Age-related Macular Degeneration

JRCT ID: jRCT2041210008

Registered date:16/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Neovascular Age-related Macular Degeneration
• Date of first enrollment: 27/11/2020
• Target sample size: 68
• Countries of recruitment: US,Japan,Hungary,Japan,The Republic of Korea,Japan,Australia,Japan,Israel,Japan,India,Japan,Poland,Japan,Russia,Japan,Slovakia,Japan,Bulgaria,Japan,Spain,Japan,Czech,Japan,Spain,Japan
• Study type: Interventional
• Intervention(s): Biological:SCD411 or Eylea (aflibercept), Dosage and administration are subject to those of Eylea, which has already been approved in Japan.

Outcome(s)

• Primary Outcome: 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 Outcome

- 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.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Sakamoto Taiji