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)
PDS With Ranibizumab (100 mg/mL)Ranibizumab (10 mg/mL)
PDS With Ranibizumab (100 mg/mL): Participants randomized to the implant arm will have the implant (filled prior to implantation with approximately 20 microliters (μL) of the 100 mg/mL formulation of ranibizumab \[approximately 2 mg dose of ranibizumab\]) surgically inserted in the study eye at the Day 1 visit following their randomization visit, or at Week 48 visit for participants randomized to the IVT arm. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed 24-week intervals.
Ranibizumab (10 mg/mL): Participants in the IVT arm will receive their first IVT injection of 50 μL of the 10 mg/mL ranibizumab (0.5 mg dose) at the Day 1 visit, which will occur at the conclusion of the randomization visit. Afterwards, participants will receive IVT ranibizumab injections of 50 μL of the 10 mg/mL formulation Q4W at each scheduled study visit until Week 44 and bi-monthly visits thereafter, followed by visits every two months until study completion.
Study summary
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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change From Baseline in Best-corrected Visual Acuity (BCVA) Score Averaged Over Weeks 36 and 40, as Assessed Using the ETDRS Visual Acuity (VA) Chart at a Starting Distance of 4 Meters — Baseline up to Week 40
Trial sites (14)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
China
Beijing Tongren Hospital
Beijing
China
West China Hospital, Sichuan University
Chengdu
China
Sichuan Provincial People's Hospital
Chengdu
China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou
China
The Second Affiliated Hospital of Harbin Medical University
Harbin
China
Qingdao Eye Hospital of Shandong First Medical University
Qingdao
China
Shanghai First People's Hospital
Shanghai
China
The First Affiliated Hospital of China Medical University
Shenyang
China
Shanxi Eye Hospital
Taiyuan
China
Tianjin Medical University Eye Hospital
Tianjin
China
Eye Hospital, Wenzhou Medical University
Wenzhou
China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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