Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)
- Conditions
- neovascular (wet) AMD
- Registration Number
- JPRN-jRCT2031220316
- Lead Sponsor
- Koelbl Stephanie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 62
Subject must be >= 50 years of age, at the time of signing the informed consent.
- Subjects must be diagnosed with neovascular (wet) AMD in the study eye.
- Subjects must have active, treatment naive, subfoveal CNV lesions secondary to neovascular (wet) AMD.
- Willingness and ability to undertake all scheduled visits and assessments.
- Any prior systemic treatment with anti-VEGF therapy
- Any condition that, in the Investigator's opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data
- Prior treatment with any investigational drugs within 30 days or 5 half-lives (whichever is longer) of the previous investigational treatment before initiation of the study treatment or concomitant enrollment in any other clinical study involving an investigational study treatment
- Subjects not suitable for participation, whatever the reason, as judged by the Investigator, including medical or psychiatric conditions, or participants potentially at risk of noncompliance to study procedures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline to Week 8 in BCVA as measured by ETDRS letter score.
- Secondary Outcome Measures
Name Time Method