A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Recruiting now · Phase 3
Conditions studied: Neovascular Age-related Macular Degeneration
In brief
The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.
Key facts
- Study ID
- NCT06847542
- Run by
- Hoffmann-La Roche
- People needed
- 250
- Starts
- 2025-11-27
- Expected to finish
- 2028-11-15
- Last updated by the study team
- 2026-07-22
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Initial diagnosis of nAMD within 24 months prior to screening
- Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to screening
- Demonstrated response to prior anti-VEGF IVT treatment since diagnosis
- Availability of historical VA data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
- Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
- BCVA of 34 letters or better using ETDRS chart at a starting distance of 4 meters at screening and enrollment visits
You may not qualify if…
- A. Prior Ocular Treatment
- Study Eye:
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)
- Previous treatment with corticosteroid intravitreal injection
- Previous intraocular device implantation
- History of vitreous hemorrhage
- History of rhegmatogenous retinal detachment
- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
- History of corneal transplant
- Either Eye:
- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the ranibizumab injections, study-related procedure preparations (including fluorescein), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study
- Prior participation in a clinical trial involving any experimental therapies for nAMD
- Prior treatment with brolucizumab or gene therapy for nAMD
- B. Macular Neovascularization/Choroidal Neovascularization (MNV/CNV) Lesion Characteristics:
- Study Eye:
- Subretinal hemorrhage that involves the center of the fovea
- Subfoveal fibrosis or subfoveal atrophy
- Either Eye:
- CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorioretinopathy, or pathologic myopia
- CNV masquerading lesions
- C. Concurrent Ocular Conditions:
- Study Eye:
- Subfoveal and/or juxtafoveal retinal pigment epithelial tear
- 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 or affect interpretation of study results
- Active intraocular inflammation
Where it is running
- Kepler Universitätskliniken GmbH - Med Campus III — Linz, Austria (enrolling)
- Landesklinikum Mistelbach — Mistelbach, Austria (enrolling)
- Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt — Mladá Boleslav, Czechia (enrolling)
- Faculty Hospital Ostrava — Ostrava, Czechia (enrolling)
- Ustredni vojenska nemocnice — Prague, Czechia (enrolling)
- Aarhus Universitetshospital — Aarhus N, Denmark (enrolling)
- Rigshospitalet Glostrup — Glostrup Municipality, Denmark (enrolling)
- Institut Ophtalmologique De l Ouest Jules Verne — Nantes, Paris, France (enrolling)
- Hopital Edouard Herriot - CHU Lyon — Lyon, France (enrolling)
- Clinique Honore Cave — Montauban, France (enrolling)
- CHNO des Quinze Vingts — Paris, France (enrolling)
- CHU Poitiers - CHR La Miletrie — Poitiers, France (enrolling)
- CHU Strasbourg - Nouvel Hopital Civil — Strasbourg, France (enrolling)
- Klinikum Chemnitz gGmbH — Chemnitz, Germany (enrolling)
- Universitätkslinikum Düsseldorf, Augenklinik — Düsseldorf, Germany (enrolling)
- Universitätsmedizin Göttingen Georg-August-Universität — Göttingen, Germany (enrolling)
- Medizinische Hochschule Hannover, Klinik für Augenheilkunde — Hanover, Germany (enrolling)
- Universitätsmedizin Rostock — Rostock, Germany (enrolling)
- Universitätsklinikum Würzburg, Augenklinik und Poliklinik — Würzburg, Germany (enrolling)
- "G.Gennimatas" General Hospital of Athens — Athens, Attica, Greece (enrolling)
- Attikon University General Hospital — Chaïdári, Greece (enrolling)
- University General Hospital of Heraklion — Heraklon, Greece (enrolling)
- University Hospital of Larissa — Larissa, Greece (enrolling)
- Ospedale Monaldi - AORN dei Colli — Naples, Campania, Italy (enrolling)
- Medizinische Universität Innsbruck — Innsbruck, Austria (enrolling)
Full record on ClinicalTrials.gov
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