SUSVIMO for Age-Related Macular Degeneration
(Belvedere Trial)
Recruiting in Palo Alto (17 mi)
+50 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Genentech, Inc.
Must be taking: Anti-VEGF
Must not be taking: Systemic anti-VEGF, Oral corticosteroids
Disqualifiers: Glaucoma, Autoimmune diseases, Cancer, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot use systemic anti-VEGF agents or chronic oral corticosteroids during the study.
What data supports the effectiveness of the treatment SUSVIMO for Age-Related Macular Degeneration?
The Port Delivery System with ranibizumab (SUSVIMO) has shown similar effectiveness to monthly eye injections of ranibizumab for treating neovascular age-related macular degeneration, with the added benefit of fewer office visits and potentially better long-term outcomes.
12345Is the Port Delivery System with Ranibizumab safe for humans?
The Port Delivery System with Ranibizumab (PDS) has been evaluated for safety in clinical trials for treating age-related macular degeneration. It is a surgically implanted device that releases medication over time, reducing the need for frequent eye injections. While it has shown to be effective, like any medical procedure, it may have associated risks, and discussing these with a healthcare provider is important.
12346How is the SUSVIMO treatment different from other treatments for age-related macular degeneration?
SUSVIMO is unique because it uses a small implant to continuously release medication into the eye, reducing the need for frequent injections and office visits, which can be burdensome for patients.
12345Eligibility Criteria
This trial is for patients with neovascular age-related macular degeneration (nAMD) who have been treated with anti-VEGF agents other than ranibizumab. They must have a history of responding to these treatments, clear ocular media, and no severe eye conditions or recent strokes. Pregnant women and those planning pregnancy are excluded.Inclusion Criteria
I have had a heart attack in the last 3 months.
I have a tear in the layer of my eye's retina.
I have had an eye injury before.
+67 more
Exclusion Criteria
I have had eye surgery in the upper outer part of my eye.
I have had bleeding in the gel-like substance inside my eye.
I have had laser treatment for age-related macular degeneration.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the Port Delivery System with Ranibizumab, with implant refill-exchanges at fixed 24-week intervals
24 weeks
Implantation on Day 1, followed by refill-exchanges every 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a focus on ocular adverse events
52 weeks
Participant Groups
The study tests the response to SUSVIMO (ranibizumab injection), refilled every 24 weeks in nAMD patients previously treated with different anti-VEGFs. It's an open-label Phase IV trial assessing treatment efficacy and impact on corneal endothelial cells.
1Treatment groups
Experimental Treatment
Group I: SUSVIMOExperimental Treatment2 Interventions
Participants will have the implant (filled prior to implantation with approximately 20 microlitres (uL) of the 100 milligrams/millilitres (mg/ml) formulation of ranibizumab \[approximately 2 milligrams (mg) dose of ranibizumab\]) surgically inserted in the study eye at the Day 1 visit following their enrollment visit. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed Q24W intervals.
Port Delivery System with Ranibizumab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Susvimo for:
- Neovascular age-related macular degeneration (nAMD)
🇪🇺 Approved in European Union as Susvimo for:
- Neovascular age-related macular degeneration (nAMD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
California Eye Specialists Medical group Inc.Pasadena, CA
California Retina ConsultantsBakersfield, CA
University Retina and Macula Associates, PCLemont, IL
Piedmont Eye CenterLynchburg, VA
More Trial Locations
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Who Is Running the Clinical Trial?
Genentech, Inc.Lead Sponsor
References
Development of the Port Delivery System with ranibizumab for neovascular age-related macular degeneration. [2023]This review provides background on the remaining unmet needs with antivascular endothelial growth factor (VEGF) therapies for the treatment of neovascular age-related macular degeneration (nAMD). We also discuss the developmental story of the Port Delivery System with ranibizumab (PDS; SUSVIMO, Genentech, Inc., South San Francisco, CA, USA).
Patient Preference and Treatment Satisfaction With a Port Delivery System for Ranibizumab vs Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. [2022]The port delivery system (PDS) with ranibizumab has demonstrated noninferior and equivalent efficacy compared with monthly intravitreal injections of ranibizumab, an anti-vascular endothelial growth factor (VEGF) agent, in patients with neovascular age-related macular degeneration (nAMD), but evaluating patient preference is important to help inform clinical decision-making.
The Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration: Results from the Randomized Phase 2 Ladder Clinical Trial. [2020]To evaluate the safety and efficacy of the Port Delivery System with ranibizumab (PDS) for neovascular age-related macular degeneration (nAMD) treatment.
Archway Randomized Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration. [2022]To evaluate the safety and efficacy of the Port Delivery System with ranibizumab (PDS) for the treatment of neovascular age-related macular degeneration (nAMD).
Evaluation of Port Delivery System with ranibizumab for the treatment of neovascular age-related macular degeneration. [2021]Current treatment of neovascular age-related macular degeneration involves periodic intravitreal injections of anti-VEGF medication, creating a burden to patients and physicians, resulting in nonadherence to recommended dosing schedules. The Port Delivery System with ranibizumab offers a long-term solution that involves implantation of a device into the pars plana and provides continuous release of anti-VEGF medication into the vitreous, thus requiring fewer office visits. The Port Delivery System has demonstrated comparable visual and anatomic outcomes to monthly injections and shows promise in alleviating the patient burden in the treatment of neovascular age-related macular degeneration, making possible better long-term real-world visual outcomes.
Port delivery system: a novel drug delivery platform to treat retinal diseases. [2021]Retinal disease treatment delivery is mostly limited to intravitreal injections and slow-release injectable implants due to structural barriers in the eye, and carry associated adverse effects and relatively high treatment burden. The Port Delivery System with ranibizumab (PDS) is a novel drug delivery device that is surgically implanted into the vitreous cavity and allows for continuous release of the anti-vascular endothelial growth factor (anti-VEGF) ranibizumab, eliminating the need for frequent intravitreal injections while maintaining therapeutic intraocular drug levels to control disease activity. Investigations of PDS are summarized in this review.