SUSVIMO for Age-Related Macular Degeneration

(Belvedere Trial)

Recruiting at 49 trial locations

Overseen By Reference Study ID Number: ML43000 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 4

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 All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

188 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 6}

How 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. ^{1 2 3 4 5}

Research Team

Clinical Trials

Principal Investigator

Genetech

Eligibility 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.

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.

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

Treatment Details

Interventions

• Intravitreal Ranibizumab Injection
• LUCENTIS (ranibizumab injection)
• Port Delivery System with Ranibizumab
• SUSVIMO (ranibizumab injection)

Trial Overview 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.

Participant Groups

Group I: SUSVIMO Experimental Treatment 2 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)

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Findings from Research

The Port Delivery System (PDS) with ranibizumab is a new long-acting treatment for neovascular age-related macular degeneration (nAMD) that continuously delivers medication for up to 6 months, addressing the issue of undertreatment that leads to vision loss.

In a phase 3 trial, the PDS demonstrated similar improvements in visual acuity compared to monthly injections of ranibizumab, with manageable adverse events, marking it as the first FDA-approved continuous delivery system for anti-VEGF therapy in nAMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of the Port Delivery System with ranibizumab for neovascular age-related macular degeneration. Adamis, AP., de Juan, E.[2023]

In a phase 3 clinical trial involving 415 patients with neovascular age-related macular degeneration (nAMD), the port delivery system (PDS) with ranibizumab showed similar treatment satisfaction compared to monthly intravitreal injections, indicating both methods are effective.

A significant majority (93.2%) of patients using the PDS preferred this method over previous intravitreal injections, suggesting that PDS could be a favorable alternative for long-term treatment in nAMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Chang, MA., Kapre, A., Kaufman, D., et al.[2022]

The Port Delivery System (PDS) with ranibizumab for treating neovascular age-related macular degeneration (nAMD) was well tolerated and showed a dose-dependent response, with the 100 mg/ml dose providing visual and anatomical outcomes similar to monthly injections of ranibizumab, but with fewer treatments required.

Patients receiving the PDS had a median time to first implant refill of up to 15 months, indicating a significant reduction in treatment frequency compared to traditional monthly injections, which could lessen the treatment burden for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration: Results from the Randomized Phase 2 Ladder Clinical Trial. Campochiaro, PA., Marcus, DM., Awh, CC., et al.[2020]

The Port Delivery System (PDS) with ranibizumab demonstrated noninferior and equivalent efficacy to monthly ranibizumab injections for treating neovascular age-related macular degeneration (nAMD), with 98.4% of patients not requiring supplemental treatment during the first 24 weeks.

However, the PDS Q24W arm experienced a higher rate of ocular adverse events (19.0%) compared to the monthly ranibizumab arm (6.0%), including serious complications like endophthalmitis and retinal detachments, mostly occurring within the first month after implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Archway Randomized Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration. Holekamp, NM., Campochiaro, PA., Chang, MA., et al.[2022]

The Port Delivery System with ranibizumab provides a long-term treatment option for neovascular age-related macular degeneration by continuously releasing anti-VEGF medication, which reduces the need for frequent intravitreal injections.

This system has shown comparable visual and anatomical outcomes to traditional monthly injections, potentially improving patient adherence and long-term visual results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Port Delivery System with ranibizumab for the treatment of neovascular age-related macular degeneration. Patel, AJ., Pieramici, DJ., Bagheri, N.[2021]

The Port Delivery System (PDS) for ranibizumab offers a continuous drug release mechanism that significantly reduces the need for frequent intravitreal injections, which are typically burdensome for patients with retinal diseases.

Preliminary studies and phase I-III trials indicate that PDS maintains effective therapeutic levels of ranibizumab, achieving visual and anatomical outcomes comparable to standard monthly injections, thus showing promise for improving treatment adherence and patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Port delivery system: a novel drug delivery platform to treat retinal diseases. Khanani, AM., Aziz, AA., Weng, CY., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development of the Port Delivery System with ranibizumab for neovascular age-related macular degeneration. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

The Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration: Results from the Randomized Phase 2 Ladder Clinical Trial. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Archway Randomized Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of Port Delivery System with ranibizumab for the treatment of neovascular age-related macular degeneration. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Port delivery system: a novel drug delivery platform to treat retinal diseases. [2021]