A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)
- Conditions
- eovascular Age-Related Macular Degeneration
- Registration Number
- JPRN-jRCT2080224626
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 640
Treatment-naive CNV secondary to AMD (nAMD)
- Ability to comply with the study protocol, in the investigator's judgment
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate <1% per year during the treatment period and for at least 3 months after the final dose of study treatment
- Other protocol-specified inclusion criteria may apply
- Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on Day 1
- Pregnancy or breastfeeding, or intention to become pregnant during the study
- CNV due to causes other than AMD in the study eye
- Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
- Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
- Uncontrolled glaucoma in the study eye
- Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
- Prior IVT administration of faricimab in either eye
- History of idiopathic or autoimmune-associated uveitis in either eye
- Active ocular inflammation or suspected or active ocular or periocular infection in either eye
- Other protocol-specified exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>confirmatory<br>Average Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 48 BCVA as measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>- Change from Baseline in BCVA Over Time <br>- Percentage of Participants Gaining >=15, >=10, >=5, or >=0 Letters in BCVA from Baseline Over Time <br>- Percentage of Participants Avoiding Loss of >=15, >=10, >=5, or >0 in BCVA from Baseline Over Time<br>- Change from Baseline in CST Over Time<br>- Change from Baseline in Total Area of CNV Lesion at Weeks 48 and 112<br>- Change from Baseline in Total Area of CNV Leakage at Weeks 48 and 112<br>- Percentage of Participants with Ocular Adverse Events <br>- Percentage of Participants with Non-Ocular Adverse Events<br>- Plasma Concentration of Faricimab Over Time