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 now · Phase 3
Conditions studied: Neovascular Age-related Macular Degeneration, nAMD
In brief
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.
Key facts
- Study ID
- NCT05562947
- Run by
- Hoffmann-La Roche
- People needed
- 68
- Starts
- 2024-06-17
- Expected to finish
- 2029-08-30
- Last updated by the study team
- 2026-08-04
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Xi'an People's Hospital (Xi'an Fourth Hospital) — Xi'an, China (enrolling)
- Tongji Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China (enrolling)
- Peking Union Medical College Hospital — Beijing, China (enrolling)
- Beijing Tongren Hospital — Beijing, China (enrolling)
- West China Hospital, Sichuan University — Chengdu, China (enrolling)
- Sichuan Provincial People's Hospital — Chengdu, China (enrolling)
- Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou, China (enrolling)
- The Second Affiliated Hospital of Harbin Medical University — Harbin, China (enrolling)
- Qingdao Eye Hospital of Shandong First Medical University — Qingdao, China (enrolling)
- Shanghai First People's Hospital — Shanghai, China (enrolling)
- The First Affiliated Hospital of China Medical University — Shenyang, China (enrolling)
- Shanxi Eye Hospital — Taiyuan, China (enrolling)
- Tianjin Medical University Eye Hospital — Tianjin, China (enrolling)
- Eye Hospital, Wenzhou Medical University — Wenzhou, China (enrolling)
- Beijing Hospital — Beijing, China
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.