A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorHoffmann-La Roche
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Susvimo PDS Implant
- Ranibizumab
Treatment groups
250 Participants
are divided into 1 treatment groupSponsors and collaborators
Hoffmann-La Roche
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov