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Study of Port Delivery System with ranibizumab given every 36 weeks in patients with neovascular age-related macular degeneration

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with neovascular Age-Related Macular Degeneration, also known as wet AMD, which is an eye condition causing vision loss due to abnormal blood vessel growth in the retina. The study tests a device called the Port Delivery System that contains the medicine ranibizumab. This system is designed to deliver medication directly into the eye through a small, implantable device, rather than through traditional eye injections.

The purpose of this research is to evaluate how well the Port Delivery System works when the medicine is refilled every 36 weeks. The medication being studied, ranibizumab, is already approved for treating wet AMD when given as regular eye injections. In this study, participants will receive the implanted delivery system and will have it refilled with medication according to a set schedule over approximately 72 weeks.

During the study, patients will have regular eye examinations and vision tests to monitor their condition. The Port Delivery System will be surgically implanted into the eye at the beginning of the study, and then the medicine will be refilled through this system. The study will compare this new delivery method to traditional eye injections and will monitor both the effectiveness of the treatment and any side effects that may occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening
Your eligibility will be evaluated if you are 50 years or older and have been diagnosed with neovascular age-related macular degeneration (nAMD) within the past 24 months
Your vision will be tested using a special chart to confirm you can see at least 34 letters at 4 meters distance
Your previous eye treatment records and images will be reviewed
Step 2
Treatment initiation
A small medical device called Port Delivery System (PDS) will be surgically implanted in your eye
The device contains ranibizumab, a medication that helps treat your eye condition
You will need to stay under observation for up to 37 days after the surgery to monitor your recovery
Step 3
Regular monitoring and refills
The device will be refilled with medication every 36 weeks
Regular eye examinations will be performed to check your vision and eye health
Your vision will be measured using the same chart as during screening
Pictures of your eye will be taken to monitor the thickness of specific areas of your retina
Step 4
Additional treatments
If needed, you may receive additional eye injections of ranibizumab between the scheduled refills
The need for extra treatment will be determined based on your eye examination results
Step 5
Study completion
The study will continue for 72 weeks (approximately 1.5 years)
Final vision assessments will be performed at weeks 68 and 72
You will be asked about your treatment preference through a questionnaire at weeks 24 and 72

Who can join the trial?

6 criteria

Must be 50 years of age or older when signing the consent form
Must have been diagnosed with neovascular age-related macular degeneration (nAMD) within the past 24 months before screening visit
Must have shown positive response to previous anti-VEGF eye injections (treatments that help prevent abnormal blood vessel growth in the eye)
Must have stable eye disease as shown on OCT scan (a detailed image of the retina) at enrollment, confirmed by specialists
Must have good enough vision to read at least 34 letters on a standard eye chart from 4 meters away (approximately equal to 20/200 vision)
Must have previous OCT scan images from when the condition was first diagnosed and before starting any treatment

Who cannot join the trial?

13 criteria

Previous eye surgery within 3 months before starting the study
Active eye infection or inflammation
History of retinal detachment (separation of the light-sensitive layer of the eye from its supporting tissue)
Uncontrolled glaucoma (increased pressure inside the eye)
Previous treatment with other medications for wet AMD in the study eye within the last 4 months
Known allergies to the study medication or its components
History of other serious eye conditions that could interfere with the study results
Pregnancy or breastfeeding
Current participation in another clinical trial
Serious medical conditions that could affect study participation
Unable to follow study instructions or attend scheduled visits
History of stroke or heart attack within the past 3 months
Active bleeding disorders or use of blood-thinning medications

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aarhus University Hospital
Verified
Aarhus, Denmark
Fakultni Nemocnice Kralovske Vinohrady
Responsive
Prague, Czechia
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

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Investigated drugs

Port Delivery System with ranibizumab (PDS)
This is a specialized implant system that delivers ranibizumab medication directly to the eye. It is designed to treat neovascular age-related macular degeneration, which is a condition that affects vision in older adults. The system works by continuously releasing the medication over time, reducing the need for frequent eye injections. The delivery system is implanted into the eye during a surgical procedure and can be refilled with medication when needed.
Ranibizumab
This is a medication used to treat eye conditions by blocking the growth of abnormal blood vessels in the back of the eye. It helps prevent vision loss and may improve vision in people with age-related macular degeneration. The medication works by targeting and inhibiting a protein that promotes the growth of new blood vessels that can damage vision.

Ranibizumab

What is already known about the treatment

Ranibizumab – A specialized medication delivered through a Port Delivery System (PDS), which is a small, refillable eye implant designed for the treatment of neovascular Age-Related Macular Degeneration (nAMD). This monoclonal antibody works by blocking vascular endothelial growth factor (VEGF), thereby reducing abnormal blood vessel growth and leakage in the retina that causes vision loss. The innovative delivery system allows for continuous release of the medication over 36 weeks, reducing the need for frequent eye injections while maintaining therapeutic levels of the drug. Ranibizumab belongs to the class of anti-VEGF agents and represents a significant advancement in the long-term management of macular degeneration, particularly for patients who require ongoing treatment.

Investigated diseases

Neovascular Age-Related Macular Degeneration (nAMD) - A progressive eye condition that develops when abnormal blood vessels grow underneath the macula in the retina. These abnormal vessels can leak fluid and blood into the retina, causing distortion of central vision. The condition typically affects people over the age of 50, gradually causing blurred or distorted central vision while peripheral vision usually remains intact. The disease affects the ability to see fine details, read, recognize faces, and perform other activities requiring detailed vision. It represents the advanced form of age-related macular degeneration, developing more rapidly than the dry form of the disease.