A Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Neovascular Age-Related Macular Degeneration (Tenaya)
- Conditions
- eovascular age-related macular degenerationMedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2018-002152-32-NL
- Lead Sponsor
- F.Hoffmann La-Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 640
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 165
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 475
- 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate the efficacy of IVT (intravitreal) injections of faricimab on change in best-corrected visual acuity (BCVA) ;Secondary Objective: • To evaluate the efficacy of faricimab on additional BCVA outcomes<br>• To evaluate the frequency of study drug administration<br>• To evaluate the efficacy of faricimab on anatomical outcome measures using optical coherence tomography (OCT) and fundus fluorescein angiography (FFA)<br>• To evaluate the ocular and non-ocular safety and tolerability of faricimab<br>• To characterize the systemic pharmacokinetics of faricimab<br>• To evaluate the immune response to faricimab<br>• To evaluate potential effects of anti-drug antibody (ADA)s;Primary end point(s): 1. Change in BCVA from baseline to average at Weeks 40, 44 and 48<br><br><br>;Timepoint(s) of evaluation of this end point: 1. Baseline (Day 1), Weeks 40, 44, and 48
- Secondary Outcome Measures
Name Time Method