A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (TENAYA)
- Conditions
- neovascular age-related macular degenerationwet AMD10047060
- Registration Number
- NL-OMON49876
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
- Age ><= 50 years , - Ability to comply with the study protocol, - For
women of childbearing potential: agreement to remain abstinent or use
acceptable contraceptive methods during the treatment period and for at least 3
months after the final dose of study treatment, - Treatment-naïve choroidal
neovascularization (CNV) secondary to AMD (nAMD) in the study eye, - BCVA of
20/32 to 20/320 (letter score of 78 to 24) in the study eye at the initiation
of treatment
- Uncontrolled blood pressure, - 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, - Presence at screening of central serous chorioretinopathy in
the study eye, - Retinal pigment epithelial tear involving the macula on Day 1
in the study eye, - On FFA/ Color fundus photograph: , o Subretinal hemorrhage
of > 50% of the total lesion area and/or that involves the fovea, o Fibrosis or
atrophy of > 50% of the total lesion area and/or that involves the fovea, -
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 , - Current vitreous
hemorrhage on Day 1 in the study eye, - Uncontrolled glaucoma in the study
eye, - Spherical equivalent of refractive error demonstrating more than 8
diopters of myopia in the study eye, - Any prior or concomitant treatment for
CNV or vitreomacular-interface abnormalities in the study eye, - Any cataract
surgery or treatment for complications of cataract surgery with steroids or YAG
laser capsulotomy in the study eye within 3 months prior to Day 1, - Any other
intraocular surgery in the study eye, - Prior periocular pharmacological or
IVT treatment for other retinal diseases in the study eye, - Prior IVT
administration of faricimab in either eye, - Active ocular inflammation or
suspected or active ocular or periocular infection in either eye
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Efficacy Objective:<br /><br>To evaluate the efficacy of IVT injections of the 6-mg dose of faricimab on<br /><br>BCVA outcomes compared with aflibercept<br /><br><br /><br>Corresponding Endpoint:<br /><br>Change from baseline in BCVA (as measured on the ETDRS chart at a starting<br /><br>distance of 4 meters) based on an average at Weeks 40, 44, and 48</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the ocular and non-ocular<br /><br>safety and tolerability of faricimab<br /><br><br /><br>To evaluate the efficacy of faricimab on<br /><br>patient-reported vision-related functioning<br /><br>and quality of life using the NEI VFQ-25<br /><br><br /><br>To characterize the systemic<br /><br>pharmacokinetics of faricimab<br /><br><br /><br>For a full list, please see protocol section 2</p><br>