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A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)

RecruitingPhase 4Ages 50 Years - anyAllGenentech, Inc.
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In plain words

What the trial is, and whether it could suit you

This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria Ocular Inclusion Criteria: * Diagnosis of nAMD prior to screening as determined by the investigator * Difference of \<10% in ECD at screening between the 2 eyes as measured by specular microscopy and determined by the independent reading center * Availability of historical visual acuity (VA) data and spectral-domain optical coherence tomography (SD-OCT). Additionally, fluorescein angiography or color fundus photography can both be used to support participant eligibility per protocol at investigator discretion * Availability of comprehensive historical anti-vascular endothelial growth factor (VEGF) injection data, including agent administered and date of administration from the time of diagnosis, or for at least 2 years prior to screening if diagnosis was made more than 2 years before screening * Response to at least two prior anti-VEGF IVT injections as determined by the investigator based on the following: * Overall decrease in nAMD disease activity detected on historical or screening OCT * Stable or improved best-corrected visual acuity (BCVA) * BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better, using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment * All subtypes of nAMD lesions are permissible * nAMD lesions at the time of diagnosis must involve the macula * Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images Exclusion Criteria Prior Ocular Treatment Study Eye: * Prior treatment with external-beam radiation therapy or transpupillary thermotherapy * Previous treatment with verteporfin injection (PDT) or corticosteroid IVT injection within 2 years of screening * Previous laser (except PDT as stated above) used for age related macular degeneration (AMD) treatment * History of corneal transplant * History of conjunctival surgery in the superotemporal quadrant * History of intraocular inflammation following anti-VEGF injection Either Eye: * Previous PDS implantation * Previous intraocular surgery (including cataract surgery) within 6 months of study enrollment * Prior vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) * Prior pars plana vitrectomy surgery * Previous intraocular device implantation, excluding intraocular lenses * History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery * Prior participation in a clinical trial involving any intravitreal agents that are not approved at time of screening * Intraocular laser therapy, including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening * Contact lens wear in either eye within 2 months of screening * Any prior penetrating ocular trauma * Any prior ocular blunt trauma affecting corneal or retinal health in the opinion of the investigator, or any ocular blunt trauma within 6 months of screening * History of corneal transplantation, including partial-thickness corneal grafts * Prior treatment with brolucizumab * Prior treatment with external-beam radiation therapy or brachytherapy * History of hypersensitivity to ranibizumab or any excipients of Susvimo Macular Neovascularization Lesion (MNV) Characteristics Study Eye: * Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5-disc area \[1.27 square millimeters (mm\^2)\] in size * Subfoveal fibrosis or subfoveal atrophy Either Eye: * MNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia * MNV masquerading lesions (e.g., cone dystrophy, adult vitelliform dystrophy, pattern dystrophy) Current or Historical Ocular Conditions Study Eye: * Retinal pigment epithelial tear * Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated, or treated within the 3 months prior to study enrollment * Current vitreous hemorrhage * Current or history of retinal detachment * Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation * Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia or evidence of pathologic myopia on depressed fundus examination * Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery * Spherical equivalent of the refractive error demonstrating more than 5 diopters of hyperopia * Preoperative refractive error that exceeds 5 diopters of hyperopia, for participants who have undergone prior refractive or cataract surgery * Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study * Scleral pathology in the superotemporal quadrant (e.g., scleral thinning or calcification) * Conjunctival pathologies in the superotemporal quadrant * History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis * Ectropion, entropion or other impairment of the upper or lower eyelid impacting lid functionality needed to protect the ocular surface from exposure * Trichiasis * Corneal neuropathy * Lagophthalmos or incomplete blink * Active or history of facial nerve palsy/paresis Fellow (Non-Study) Eye: โ€ข Concurrent or history of PDS implantation Either Eye: * Aphakia or absence of the posterior capsule * Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition o
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What it tests

  • PDS Implant With Ranibizumab 100 mg/ml
  • LUCENTIS (Ranibizumab Injection)
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Where

52 sites
Barnet Dulaney Perkins Eye Center
Mesa, United States
California Retina Consultants
Bakersfield, United States
Retina Associates of Southern California
Huntington Beach, United States
California Eye Specialists Medical group Inc.
Pasadena, United States
Retinal Consultants Med Group
Sacramento, United States
University of California San Francisco
San Francisco, United States
Orange County Retina Med Group
Santa Ana, United States
Macula Retina Vitreous Research Institute
Torrance, United States

โ€ฆand 44 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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