Evaluating a new delivery system for treating eye disease in Chinese patients
A Phase III, Multicenter, Randomized, Visual Assessor-masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Chinese Patients With Neovascular Age-related Macular Degeneration
This study is testing a new way to deliver eye treatment that could help Chinese patients with a specific type of age-related vision loss get their medicine less often and possibly feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | ranibizumab, brolucizumab, radiation |
| Locations | 16 sites (Beijing and 15 other locations) |
| Trial ID | NCT05562947 on ClinicalTrials.gov |
What this trial studies
This study assesses the effectiveness, safety, and pharmacokinetics of a Port Delivery System (PDS) that administers ranibizumab every 24 weeks compared to the standard intravitreal injection given every 4 weeks in Chinese participants with neovascular age-related macular degeneration (nAMD). Participants must have a recent diagnosis of nAMD and a history of response to anti-VEGF treatments. The study aims to determine if the PDS can provide a more convenient and effective treatment option for patients suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates are Chinese individuals diagnosed with nAMD who have previously responded to anti-VEGF treatments.
Not a fit: Patients who have not previously responded to anti-VEGF treatments or have other ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the frequency of treatments required for patients with nAMD.
How similar studies have performed: Other studies have shown promising results with similar delivery systems for ocular treatments, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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 * 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 intravitreal 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
Where this trial is running
Beijing and 15 other locations
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
- Beijing Hospital — Beijing, China (Withdrawn)
- Beijing Tongren Hospital — Beijing, China (Recruiting)
- West China Hospital, Sichuan University — Chengdu, China (Recruiting)
- Sichuan Provincial People's Hospital — Chengdu, China (Recruiting)
- Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou, China (Recruiting)
- The Second Affiliated Hospital of Harbin Medical University — Harbin, China (Recruiting)
- Qingdao Eye Hospital of Shandong First Medical University — Qingdao, China (Recruiting)
- Shanghai First People's Hospital — Shanghai, China (Recruiting)
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (Active_not_recruiting)
- The First Affiliated Hospital of China Medical University — Shenyang, China (Recruiting)
- Shanxi Eye Hospital — Taiyuan, China (Recruiting)
- Tianjin Medical University Eye Hospital — Tianjin, China (Recruiting)
- Eye Hospital, Wenzhou Medical University — Wenzhou, China (Recruiting)
- Tongji Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China (Recruiting)
- Xi'an People's Hospital (Xi'an Fourth Hospital) — Xi'an, China (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: YR42983, https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.