RecruitingPHASE3INTERVENTIONAL

A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD

This study is investigating a new treatment for wet Age-related Macular Degeneration (AMD), a common eye condition that can affect your vision. Instead of regular eye injections, this trial uses a small, refillable implant called Susvimo PDS, which stays in your eye and slowly releases medicine. The main goal is to see if refilling this implant every 36 weeks (about every 9 months) works well and is safe for patients. The medicine used is ranibizumab, a treatment already used for wet AMD. Researchers want to know if this approach can keep vision stable and improve quality of life, possibly meaning fewer clinic visits for patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

250

Start

27 Nov 2025

Estimated completion

15 Nov 2028

Neovascular Age-related Macular Degeneration

What is this study about?

Wet Age-related Macular Degeneration, or wet AMD, is an eye condition that can cause blurred vision or blind spots. It happens when new, abnormal blood vessels grow under the macula, the part of your eye responsible for sharp, central vision. These vessels can leak blood and fluid, damaging the macula. Currently, one common treatment involves regular injections of medicine into the eye to stop these vessels from growing.

This study is looking at a new way to deliver this medicine using a small, refillable implant called a Port Delivery System (PDS) with ranibizumab (also known by its brand name, Susvimo). This implant is placed in your eye and slowly releases the medicine over time. The idea is that instead of needing frequent injections, you would only need the implant refilled every 36 weeks, which is about every 9 months.

The main purpose of this research is to check how effective and safe this PDS implant is when refilled every 36 weeks. Researchers will also look at how this treatment affects patients' daily lives and their vision. If successful, this could mean fewer trips to the clinic for eye injections and a more convenient way to manage wet AMD.

Key takeaways

Tests a new refillable implant (Susvimo PDS) for wet AMD.
Aims to reduce the frequency of eye treatments to every 36 weeks.
Uses ranibizumab, a known wet AMD medicine.
For adults aged 50 and older with previously treated wet AMD.
Could mean fewer clinic visits for patients.

Who may be eligible?

To join this study, participants generally need to have been diagnosed with wet AMD within the last two years and have already received at least three anti-VEGF eye injections for their AMD in the six months before the study starts. It's important that their previous anti-VEGF treatments have shown a positive effect on their condition, and there must be old records of their vision and eye scans available from before they started treatment for AMD.

There are also some reasons why someone might not be able to join. For example, if you've had certain eye surgeries like a vitrectomy, submacular surgery, or glaucoma surgery in the eye being studied, you wouldn't be able to take part. Similarly, if you've had previous steroid injections or another type of eye implant in that eye, you wouldn't be eligible. They also can't have certain other eye conditions or allergic reactions to the study medication or related procedures. If you've previously been involved in a study testing experimental AMD treatments, or if you've had specific types of bleeding or scarring in the central part of your eye, you might not be able to join.

This study is open to both men and women aged 50 and older. Your doctor will carefully review all these points to see if this study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you been diagnosed with wet AMD in the last 2 years?
Have you had at least 3 anti-VEGF eye injections for your AMD in the last 6 months?
Has your previous AMD treatment helped your vision?
Do you have good vision (34 letters or better) in the eye being studied?
Have you NOT had certain eye surgeries (e.g., vitrectomy, glaucoma surgery) on the study eye?
Have you NOT had previous steroid injections or another eye implant in the study eye?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you would receive the Susvimo PDS implant in your eye. This implant would then be refilled with ranibizumab medicine every 36 weeks (approximately 9 months). Throughout the study, you would have regular appointments for check-ups, which include vision tests, eye scans (like OCT), and other eye examinations. These visits will help the doctors monitor your eye health and the effectiveness of the treatment. The total length of the study would involve several years of follow-up to ensure the long-term safety and effectiveness of the implant.

Potential risks and benefits

Participating in this study might offer the benefit of a less frequent treatment schedule for your wet AMD compared to regular injections, potentially improving your convenience and quality of life. However, like all medical procedures, implanting and refilling the device carries potential risks, including infection, bleeding, or other complications related to eye surgery. The medicine itself also has known side effects, which your doctor will explain. It's important to remember that you are free to withdraw from the study at any time, for any reason, without affecting your standard care.

Locations (57)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Medizinische Universität Innsbruck
Verified postcode
Innsbruck, Austria· Recruiting
Kepler Universitätskliniken GmbH - Med Campus III
Verified postcode
Linz, Austria· Recruiting
Landesklinikum Mistelbach
Verified postcode
Mistelbach, Austria· Recruiting
Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt
Verified postcode
Mladá Boleslav, Czechia· Recruiting
Faculty Hospital Ostrava
Verified postcode
Ostrava, Czechia· Recruiting
Aarhus Universitetshospital
Verified postcode
Aarhus N, Denmark· Recruiting
Rigshospitalet Glostrup
Verified postcode
Glostrup Municipality, Denmark· Recruiting
Institut Ophtalmologique De l Ouest Jules Verne
Verified postcode
Nantes, France· Recruiting
Hopital Edouard Herriot - CHU Lyon
Verified postcode
Lyon, France· Recruiting
Clinique Honore Cave
Verified postcode
Montauban, France· Recruiting
CHNO des Quinze Vingts
Verified postcode
Paris, France· Recruiting
CHU Poitiers - CHR La Miletrie
Verified postcode
Poitiers, France· Recruiting

Common questions

What is wet AMD?

Wet AMD is an eye condition where abnormal blood vessels grow in the back of your eye, causing vision changes.

What is the 'Susvimo PDS Implant'?

It's a small, refillable device placed in your eye that slowly releases medicine for wet AMD, aiming to reduce the need for frequent injections.

How often would the implant be refilled?

The implant would be refilled every 36 weeks, which is about every nine months, during a clinic visit.

What medicine is used in this study?

The study uses ranibizumab, a medicine already approved for treating wet AMD.

Is this study only for people who haven't had treatment before?

No, it's for people who have already started treatment for wet AMD and have responded well to it.

How to find out more

Reference Study ID Number: MR45625 https://forpatients.roche.com/

global-roche-genentech-trials@gene.com 888-662-6728 (U.S.) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.