RecruitingPHASE3INTERVENTIONAL

Extension Study for the Port Delivery System With Ranibizumab (Portal)

This study is an extension of previous research into a special eye implant called the Port Delivery System (PDS), which releases medicine (ranibizumab) slowly over time. The main goal is to see how safe this implant is in the long term for people with 'wet' age-related macular degeneration (nAMD). It's for patients who have already taken part in specific earlier studies like "Ladder," "Archway," or "Velodrome." Researchers want to understand if the PDS continues to work well and safely over many years. There are also smaller parts of the study looking at ways to handle certain side effects, such as a procedure to prevent bleeding after the implant, and checking the safety of replacing the implant if needed.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

1,000

Start

20 Sep 2018

Estimated completion

31 Dec 2029

Neovascular Age-Related Macular Degeneration

What is this study about?

This study, called "Portal," is an important follow-up to research on a new way to treat an eye condition called 'wet' age-related macular degeneration, or nAMD. This condition affects your central vision. Instead of regular eye injections, this study uses a small, special implant that's placed in your eye during a minor surgical procedure. This implant slowly releases medicine (ranibizumab) over several months, meaning you might need fewer trips to the clinic for treatment.

The main aim of "Portal" is to check if this implant is safe and works well over a long period. It's designed for people who have already been part of previous studies about this implant, like "Ladder" or "Archway." By continuing to follow these patients, doctors can learn more about the long-term benefits and any potential side effects of this new treatment method. This helps ensure it can be a safe and effective option for many people in the future.

There are also two smaller parts of the study. One part looks at a special laser treatment called Transscleral Photocoagulation (TPC) to see if it can help prevent a rare side effect, like bleeding, that can happen after the implant is put in. The other part checks the safety of replacing the implant if it needs to be changed. Both of these mini-studies aim to make the treatment even safer and more comfortable for patients.

Key takeaways

This study is for long-term monitoring of an eye implant (PDS) for 'wet' AMD.
It's only for people who have been in specific previous PDS studies.
The implant delivers medicine to reduce the need for frequent eye injections.
The study checks the implant's safety and effectiveness over time.
Smaller parts of the study look at preventing surgical side effects and implant replacement safety.
You must be willing to attend all scheduled appointments.

Who may be eligible?

This study is specifically for people who have already taken part in certain previous studies about this eye implant. You would need to have completed one of those original studies, such as the "Ladder," "Archway," or "Velodrome" studies, without having left them early.

To join, you must be willing and able to come for all scheduled appointments and check-ups. If you are a woman who could become pregnant, you'll need to agree to either not have sex or use reliable birth control during the study and for a certain time afterward.

There are some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or planning to get pregnant. Also, if you have other eye problems or serious health conditions that could make the treatment unsafe for you, or if you need to take certain medications that are not allowed in the study, you probably wouldn't be able to take part. The smaller laser sub-study has more specific rules, such as needing to have had 'wet' AMD for less than two years and having already received other eye injections.

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 I previously completed the 'Ladder,' 'Archway,' or 'Velodrome' eye implant study?
Am I able and willing to attend all scheduled medical appointments for the study?
If I am a woman who could become pregnant, am I willing to use effective birth control or avoid sex during the study?
Am I currently pregnant or breastfeeding, or planning to become pregnant soon?
Do I have any other severe eye conditions or major health issues that might prevent me from safely joining?
Do I take any medications that the study rules might not allow?

Answer every question to see your result.

What does participation involve?

As this is an extension study, your participation will involve continued follow-up visits and assessments as determined by the study protocol. The main goal is to monitor the long-term safety and effectiveness of the PDS implant. This will include regular eye examinations, vision tests, and possibly scans of your eye. You will continue to have the ranibizumab medicine delivered by the implant, and the device will be refilled periodically. The exact number and frequency of visits, as well as the total duration of your participation, will depend on which previous study you participated in and if you join any of the sub-studies. For example, participants in the re-implantation sub-study could be followed for up to 72 weeks after their implant is replaced. You will be closely monitored for any side effects.

Potential risks and benefits

Participating could offer the potential benefit of continued long-term treatment for your 'wet' AMD with potentially fewer visits for injections. However, as with any medical procedure, there are potential risks, including those associated with eye surgery and the medication itself. These might include eye irritation, implant-related issues, or changes to vision. The laser sub-study also carries a small risk of issues related to the laser treatment. You will receive detailed information about all potential risks before deciding to join. Remember, taking part in any study is completely voluntary, and you are free to withdraw at any time without affecting your usual medical care.

Locations (165)

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

Retinal Research Institute, LLC
Verified postcode
Phoenix, United States· Completed
Arizona Retina and Vitreous Consultants
Verified postcode
Phoenix, United States· Completed
Barnet Dulaney Perkins Eye Center
Verified postcode
Phoenix, United States· Active not recruiting
Associated Retina Consultants
Verified postcode
Phoenix, United States· Completed
Retinal Consultants of Arizona
Verified postcode
Phoenix, United States· Completed
California Retina Consultants
Verified postcode
Bakersfield, United States· Completed
Retina-Vitreous Associates Medical Group
Verified postcode
Beverly Hills, United States· Completed
The Retina Partners
Verified postcode
Encino, United States· Active not recruiting
Jacobs Retina center at the Shiley eye Institute UCSD
Verified postcode
La Jolla, United States· Completed
Jules Stein Eye Institute/ UCLA
Verified postcode
Los Angeles, United States· Completed
N CA Retina Vitreous Assoc
Verified postcode
Mountain View, United States· Completed
Retina Consultants, San Diego
Verified postcode
Poway, United States· Completed

Common questions

What is 'wet' age-related macular degeneration (nAMD)?

'Wet' AMD is an eye condition that affects the central part of your vision, making everyday tasks like reading or recognising faces difficult. It happens when abnormal blood vessels grow in the eye and leak fluid.

What is the Port Delivery System (PDS) implant?

It's a tiny, refillable device placed in your eye that releases medicine slowly over time, aiming to reduce the number of direct eye injections you might need for 'wet' AMD.

Why is this study only for people from previous studies?

This 'extension' study builds on earlier research. It helps doctors understand how the implant works over many years in people who have already safely used it, gathering long-term safety and effectiveness information.

What is ranibizumab?

Ranibizumab is a medicine used to treat 'wet' AMD. It works by blocking a protein that causes the abnormal blood vessels to grow and leak in the eye.

Will I have to pay to be in the study?

Clinical trials generally cover the costs of study-related treatments and visits. You should always clarify any potential costs with the study team before participating.

How to find out more

Reference Study ID Number: GR40549 https://forpatients.roche.com/

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

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