Neovascular age-related macular degeneration MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
F.Hoffmann La-Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 • To evaluate the frequency of study drug administration • To evaluate the efficacy of faricimab on anatomical outcome measures using optical coherence tomography (OCT) and fundus fluorescein angiography (FFA) • To evaluate the ocular and non-ocular safety and tolerability of faricimab • To characterize the systemic pharmacokinetics of faricimab • To evaluate the immune response to faricimab • 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 ;Timepoint(s) of evaluation of this end point: 1. Baseline (Day 1), Weeks 40, 44, and 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1-6. Baseline to Week 112 7-8. Week 48, 60, and 112 9-15. Baseline to Week 112 16-17. Baseline, Week 48 and 112 18-19. Up to Week 112 20. Week 1, 4, 16, 20, 48, 76, 112 21-22. Week 1, 4, 20, 48, 76, 112 ;Secondary end point(s): 1. Change from baseline in BCVA over time 2. Proportion of patients gaining >= 15, >= 10, >= 5, or >= 0 letters in BCVA from baseline over time 3. Proportion of patients avoiding loss of >= 15, >= 10, >=5, or >= 0 letters in BCVA from baseline over time 4. Proportion of patients with BCVA Snellen equivalent of 20/40 or better over time 5. Proportion of patients gaining >= 15 letters or achieving BCVA of >= 84 letters over time 6. Proportion of patients with BCVA Snellen equivalent of 20/200 or worse over time 7. Proportion of patients on different treatment intervals at Weeks 48, 60, and 112 8. Number of study drug injections received through Weeks 48, 60, and 112 9. Change from baseline in CST based on an average at Weeks 40, 44, and 48 10. Change from baseline in CST over time 11. Proportion of patients with absence of intraretinal fluid over time 12. Proportion of patients with absence of subretinal fluid over time 13. Proportion of patients with absence of intraretinal and subretinal fluid over time 14. Proportion of patients with absence of intraretinal cysts over time 15. Proportion of patients with absence of pigment epithelium detachment over time 16. Change from baseline in total area of CNV lesion at Week 48 and Week 112 17. Change from baseline in total area of leakage at Week 48 and Week 112 18. Incidence and severity of ocular adverse events 19. Incidence and severity of non-ocular adverse events 20. Plasma concentration of faricimab over time 21. Presence of ADAs during the study relative to the presence of ADAs at baseline 22. Relationship between ADA status and efficacy, safety, or pharmacokinetic endpoints | — |
Countries
Argentina, Australia, Austria, Bulgaria, China, Denmark, France, Germany, Hong Kong, Hungary, Italy, Korea, Republic of, Poland, Portugal, Russian Federation, Singapore, Spain, Taiwan, Turkey, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche LTD
Outcome results
None listed