A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Choroidal Neovascularization Secondary to Pathologic Myopia - CR44829

F. Hoffmann-La Roche AG0 个研究点目标入组 280 人开始时间: 2023年11月17日最近更新: 2024年8月21日

适应症

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•1. Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests, 2. Treatment-naïve choroidal neovascularization (CNV) secondary to myopia, 3. Diagnosis of active myopic CNV in the study eye confirmed by ocular examination and CRC review, 4. BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and assessed at the initial testing distance of 4 meters (see the BCVA manual for additional details) on Day 1, 5. Presence of at least 1 of the following lesion types (determined by CRC): ?Subfoveal (presence of abnormal neovasculature in the avascular central fovea) ?Juxtafoveal (presence of abnormal neovasculature not under the center of the fovea but = 200 um from the center) with involvement of the central macular area ?Extrafoveal (presence of abnormal neovasculature > 200 um from the center of the fovea) with involvement of the central macular area ?Margin of the optic disc (presence of abnormal neovasculature at peripapillary area) with involvement of the central macular area, 6. Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis

•1. CNV due to causes other than pathologic myopia, such as neovascular age-related macular degeneration, ocular histoplasmosis, trauma, angioid streaks, choroidal rupture, or uveitis, etc, 2. Any history of macular pathology unrelated to pathologic myopia affecting vision or contributing to the presence of intraretinal or subretinal fluid, 3. Presence at screening of central serous chorioretinopathy or myopic tractional maculopathy. Retinal pigment epithelial tear involving the macula on Day 1, 4. Non-functioning non-study eye, defined as either: ?BCVA Snellen equivalent of 20/200 or worse ?No physical presence of non-study eye (i.e., monocular), 5. Prior IVT administration of faricimab in either eye, 6. History of idiopathic or autoimmune-associated uveitis in either eye. Active ocular inflammation (anterior, intermediate or posterior uveitis, grade trace or above) or suspected or active ocular or periocular infection in either eye on Day 1

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