A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)
Recruiting
Phase 3Interventional Study
Neovascular Age-related Macular DegenerationnAMD
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
68 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Who this trial is looking for
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This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg/mL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in Chinese participants with nAMD.
Trial Locations
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Status
Eligibility Criteria
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 (SOC) within 6 months prior to the screening visit
* Demonstrated respons…
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 (SOC) within 6 months prior to the screening visit
* Demonstrated response to prior anti-VEGF IVT treatment since diagnosis
* Availability of historical VA data prior to the first anti-VEGF treatment for nAMD up 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 starting distance of 4 meters
* All subtypes of nAMD lesions are permissible
* Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), indocyanine green angiography (ICGA), fundus autofluorescence (FAF), and optical coherence tomography (OCT) images
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 transpupillary thermotherapy
* Previous treatment with corticosteroid IVT injection or corticosteroid implants
* 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 the randomization visit
* Prior treatment with IVT treatments for geographic atrophy
* Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye that may affect the implantation, subsequent tissue 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/or devices, within 3 months or five elimination half-lives of the investigational therapy, 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 is greater 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 months prior 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 of myopia
* Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery
* Intraocular surgery (including cataract surgery) within 3 months preceding the randomization visit
* Uncontrolled ocular hypertension or glaucoma
* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
* 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
Contacts
Reference Study ID Number: YR42983 https://forpatients.roche.com/ No attachments to email below.
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CONTACT
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