Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
PDS With Ranibizumab (100 mg/mL)
PDS with ranibizumab (100 mg/mL)
Ranibizumab (10 mg/mL)
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Initial diagnosis of nAMD within 9 months prior to the screening visit
Previous treatment with at least three anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to thescreening visit
Demonstrated response to prior anti-VEGF IVT treatment since diagnosis
Availability of historical VA data prior to the first anti-VEGF treatment for nAMDup to the screening visit
BCVA of 34 letters or better (20/200 or better approximate Snellen equivalent),using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a startingdistance of 4 meters
All subtypes of nAMD lesions are permissible
Sufficiently clear ocular media and adequate pupillary dilation to allow foranalysis and grading by the central reading center of fundus photography (FP),fluorescein angiography (FA), indocyanine green angiography (ICGA), fundusautofluorescence (FAF), and optical coherence tomography (OCT) images
Exclusion
Exclusion Criteria:
A. Prior Ocular Treatment Study Eye
History of vitrectomy surgery, submacular surgery, or other surgical intervention,all for AMD
Prior treatment with Visudyne, external-beam radiation therapy, or transpupillarythermotherapy
Previous treatment with corticosteroid IVT injection
Previous intraocular device implantation (not including intraocular lens implants)
Previous laser (any type) used for age-related macular degeneration (AMD) treatment
Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to therandomization visit
Prior treatment with intravitreal treatments for geographic atrophy
Concurrent conjunctival, Tenon's capsule, and/or scleral condition in thesupero-temporal quadrant of the eye that may affect the implantation, subsequenttissue coverage, and refill-exchange procedure of the PDS implant
Either Eye
Prior treatment with brolucizumab
Prior gene therapy for nAMD or other ocular diseases
Previous participation in any ocular disease studies of investigational drugs and/ordevices, within 3 months or five elimination half-lives of the investigationaltherapy, whichever is longer, preceding the screening visit
B. Choroidal Neovascularization (CNV) Lesion Characteristics
Study Eye
Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage isgreater than 0.5 disc area (1.27 millimeter square [mm^2]) in size at screening
Subfoveal fibrosis or subfoveal atrophy
Either Eye • CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia
C. Concurrent Ocular Conditions Study Eye
Retinal pigment epithelial tear
Any concurrent intraocular condition
Active intraocular inflammation (grade trace or above)
History of vitreous hemorrhage
History of rhegmatogenous retinal detachment
History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 monthsprior to the randomization visit
History of pars plana vitrectomy surgery
Aphakia or absence of the posterior capsule
Spherical equivalent of the refractive error demonstrating more than 8 diopters ofmyopia
Preoperative refractive error that exceeds 8 diopters of myopia, for participantswho have undergone prior refractive or cataract surgery
Intraocular surgery (including cataract surgery) within 3 months preceding therandomization visit
Uncontrolled ocular hypertension or glaucoma
History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucomasurgery
History of corneal transplant
Fellow (Non-Study) Eye
• Non-functioning fellow eye
Either Eye
Any history of uveitis
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
Study Design
Connect with a study center
Beijing Hospital
Beijing, 100730
ChinaSite Not Available
Beijing Tongren Hospital
Beijing, 100730
ChinaActive - Recruiting
Peking Union Medical College Hospital
Beijing, 100032
ChinaActive - Recruiting
Beijing Hospital
Beijing 1816670, 100730
ChinaSite Not Available
Beijing Tongren Hospital
Beijing 1816670, 100730
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing 1816670, 100032
ChinaActive - Recruiting
Beijing Hospital
Beijing City, 100006
ChinaActive - Recruiting
Peking Union Medical College Hospital
Beijing City, 100032
ChinaSite Not Available
Sichuan Provincial People's Hospital
Chengdu, 610072
ChinaActive - Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
ChinaActive - Recruiting
Sichuan Provincial People's Hospital
Chengdu 1815286, 610072
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu 1815286, 610041
ChinaActive - Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, 510060
ChinaActive - Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou 1809858, 510060
ChinaSite Not Available
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou City, 510060
ChinaSite Not Available
The Second Affiliated Hospital of Harbin Medical University
Harbin, 150081
ChinaActive - Recruiting
The Second Affiliated Hospital of Harbin Medical University; ophthalmology department
Harbin, 150081
ChinaActive - Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin 2037013, 150081
ChinaSite Not Available
Qingdao Eye Hospital of Shandong First Medical University
Qingdao, 266109
ChinaActive - Recruiting
Qingdao Eye Hospital of Shandong First Medical University
Qingdao 1797929, 266109
ChinaSite Not Available
Qingdao Eye Hospital of Shandong First Medical University
Qingdao City, 266109
ChinaSite Not Available
Shanghai First People's Hospital
Shanghai, 200080
ChinaActive - Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
ChinaSite Not Available
Shanghai First People's Hospital
Shanghai 1796236, 200080
ChinaSite Not Available
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai 1796236, 200092
ChinaSite Not Available
The First Affiliated Hospital of China Medical University
Shenyang, 110001
ChinaActive - Recruiting
The First Affiliated Hospital of China Medical University
Shenyang 2034937, 110001
ChinaSite Not Available
The First Affiliated Hospital of China Medical University
Shenyang City, 110001
ChinaSite Not Available
Shanxi Eye Hospital
Taiyuan, 030002
ChinaActive - Recruiting
Shanxi Eye Hospital
Taiyuan 1793511, 030002
ChinaSite Not Available
Shanxi Eye Hospital
Taiyuan City, 030002
ChinaSite Not Available
Tianjin Medical University Eye Hospital
Tianjin, 300070
ChinaActive - Recruiting
Tianjin Medical University Eye Hospital
Tianjin 1792947, 300070
ChinaSite Not Available
Tianjin Medical University Eye Hospital
Tianjin City, 300070
ChinaSite Not Available
Eye Hospital, Wenzhou Medical University
Wenzhou, 325027
ChinaActive - Recruiting
Eye Hospital, Wenzhou Medical University
Wenzhou 1791388, 325027
ChinaSite Not Available
Eye Hospital, Wenzhou Medical University
Wenzhou City, 325027
ChinaSite Not Available
Central Theater General Hospital of the Chinese People's Liberation Army
Wuhan, 430012
ChinaSite Not Available
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430030
ChinaActive - Recruiting
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan 1791247, 430030
ChinaSite Not Available
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City, 430030
ChinaSite Not Available
Xi'an People's Hospital (Xi'an Fourth Hospital)
XI An,
ChinaSite Not Available
Xi'an People's Hospital (Xi'an Fourth Hospital)
Xi'an,
ChinaActive - Recruiting
Xi'an People's Hospital (Xi'an Fourth Hospital)
Xi'an 1790630,
ChinaSite Not Available
Xuzhou No.1 Peoples Hospital
Xuzhou,
ChinaSite Not Available

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