Clareo Health | Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Treatment-naive CNV secondary to AMD (nAMD)
Subfoveal or juxtafoveal CNV with a subfoveal component related to the CNV activity by fundus fluorescein angiography (FFA) or spectral-domain optical coherence tomography (SD-OCT; as evidenced by subretinal fluid, subretinal hyperreflective material, evidence of leakage, or hemorrhage)
CNV lesion of all types with: total lesion size (including blood, atrophy, fibrosis, and neovascularization) of 6 disc areas or less by FFA; and CNV component area of at least 50% of total lesion size by FFA; and active CNV confirmed by FFA (evidence of leakage); and CNV exudation confirmed by SD-OCT (presence of fluid)
BCVA letter score of 73 to 24 letters (inclusive) on ETDRS-like charts (20/40-20/320 Snellen equivalent) on day 1
Clear ocular media and adequate pupillary dilatation to allow acquisition of good-quality retinal images to confirm diagnosis
You may not be if
CNV due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis
Central serous chorioretinopathy at screening
Retinal pigment epithelial tear involving the macula
On FFA: subretinal hemorrhage, fibrosis, or atrophy of more than (\>)50% of the total lesion area and/or that involves the fovea
Any prior or concomitant treatment for CNV including (but not restricted to) IVT treatment (steroids, anti-VEGF, tissue plasminogen activator, ocriplasmin, C3F8 gas, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or surgical intervention
Cataract surgery within 3 months of baseline assessments
Any other intraocular surgery (pars plana vitrectomy, glaucoma surgery, corneal transplant, radiotherapy)
Prior IVT treatment (including anti-VEGF medication) except for management of cataract complication with steroid IVT treatment
Prior periocular pharmacological intervention for other retinal diseases
Any concurrent intraocular condition in the study eye (eg, amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the course of the study
Active intraocular inflammation (grade trace or above) in the study eye on day 1 (before randomization)
Current vitreous hemorrhage in the study eye
Uncontrolled glaucoma (eg, progressive loss of visual fields or defined as IOP ≥25 mm Hg despite treatment with antiglaucoma medication) in the study eye
Spherical equivalent of refractive error demonstrating more than 8 diopters of myopia in the study eye
History of idiopathic or autoimmune-associated uveitis in either eye
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye on day 1 (before randomization)
Any major illness or major surgical procedure within 1 month before screening
Uncontrolled blood pressure (defined as systolic \>180 mm Hg and/or diastolic \>100 mm Hg while participant at rest). If a participant's initial reading exceeded these values, a second reading was taken later on the same day, or on another day during the screening period. If the participant's blood pressure was controlled by antihypertensive medication, the participant was taking the same medication continuously for at least 30 days before day 1
Stroke or myocardial infarction within 3 months before day 1
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory findings giving reasonable suspicion of a condition that contraindicated the use of the investigational drug or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator
Pregnant or breastfeeding, or intended to become pregnant during the study
Known hypersensitivity to ranibizumab, fluorescein, any ingredients of the formulation used, dilating eye drops, or any of the anesthetic and antimicrobial drops used
Treatment with investigational therapy within 3 months before initiation of study treatment
