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Study on the Effectiveness and Safety of Ranibizumab for Patients with Wet Age-Related Macular Degeneration Using a 36-Week Refill System

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a condition called neovascular age-related macular degeneration (nAMD), which is a type of eye disease that can lead to vision loss. The study is testing a treatment called ranibizumab, which is delivered through a special device known as the Port Delivery System. This system allows the medication to be released slowly over time. The purpose of the study is to evaluate how effective and safe this treatment is when refilled every 36 weeks compared to every 24 weeks.

Participants in the study will receive the treatment through an implantation procedure. The study will last for a period of time, during which participants will have regular check-ups to monitor their vision and overall health. The study will compare the changes in vision between the two refill schedules to determine which is more beneficial for patients with nAMD.

Throughout the study, participants will be monitored for any side effects or changes in their condition. The study aims to provide valuable information on the best way to manage nAMD using the Port Delivery System with ranibizumab, potentially offering a new option for those affected by this eye disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and screening
The initial visit involves a comprehensive eye examination to confirm the diagnosis of neovascular age-related macular degeneration (nAMD).
Eligibility is assessed based on previous treatments and visual acuity data. The eye must have been treated with at least three anti-VEGF injections in the past six months.
Step 2
Baseline assessment
A baseline assessment is conducted to measure the best-corrected visual acuity (BCVA) using the ETDRS chart.
Additional imaging tests such as fundus photography and OCT are performed to evaluate the condition of the eye.
Step 3
Implantation procedure
The Port Delivery System (PDS) with ranibizumab is implanted in the eye. This device allows for continuous delivery of the medication.
The procedure is performed under local anesthesia and involves a small incision in the eye.
Step 4
Follow-up visits
Regular follow-up visits are scheduled to monitor the eye's response to treatment and the condition of the implant.
Visual acuity is assessed, and any adverse effects are recorded.
Step 5
Refill-exchange procedure
The PDS is refilled with ranibizumab 100 mg/mL every 36 weeks or 24 weeks, depending on the assigned group.
This procedure is similar to the initial implantation and is performed in a clinical setting.
Step 6
Final assessment
At the end of the study period, a final assessment is conducted to evaluate changes in visual acuity and overall eye health.
Patient satisfaction with the treatment is also measured using questionnaires.

Who can join the trial?

8 criteria

The patient must have been diagnosed with **neovascular age-related macular degeneration (nAMD)** within the last 9 months before the screening visit. **Neovascular age-related macular degeneration** is an eye condition that can cause vision loss.
The patient should have received at least three treatments with anti-VEGF injections for nAMD in the eye within the last 6 months before the screening visit. **Anti-VEGF injections** are treatments that help reduce vision loss in certain eye conditions.
The patient must have past records of their vision before starting anti-VEGF treatment for nAMD and up to the time they join the study.
The patient should have a **best-corrected visual acuity (BCVA)** of 34 letters or better. **Best-corrected visual acuity** is a measure of the best vision a person can achieve with glasses or contact lenses, tested using a special chart.
The patient can have any type of nAMD lesions, but these lesions must affect the **macula**, which is the central part of the retina responsible for sharp vision.
The patient must have clear enough eye structures and adequate pupil dilation to allow for detailed eye imaging tests. These tests include fundus photography, fluorescein angiography, fundus autofluorescence imaging, and OCT images, which help doctors see inside the eye.
Both male and female patients are eligible to participate in the study.
The study includes patients who may be considered part of a vulnerable population.

Who cannot join the trial?

9 criteria

Patients who have any other eye diseases that could affect vision.
Patients who have had eye surgery within the last three months.
Patients who have an eye infection or inflammation.
Patients who are allergic to the study medication or any of its ingredients.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse.
Patients who have a serious medical condition that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend study visits.

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Verified sites

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

Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium
Ludwig Maximilian University Of Munich
Responsive
Munich, Germany

Trial locations

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Investigated drugs

Ranibizumab is a medication used in this clinical trial to treat patients with neovascular age-related macular degeneration, a condition that affects vision. In this study, ranibizumab is delivered through a special device called the port delivery system. This system allows the medication to be released slowly over time, reducing the need for frequent injections. The trial is investigating how effective and safe it is to refill this system every 36 weeks compared to every 24 weeks, by measuring changes in the patients' vision.

Ranibizumab

What is already known about the treatment

Ranibizumab – Ranibizumab is administered through a specialized port delivery system, which is implanted in the eye and allows for the controlled release of the medication. It is currently being studied in clinical trials for its effectiveness in treating neovascular age-related macular degeneration (nAMD). This medication works by inhibiting a protein called vascular endothelial growth factor (VEGF), which plays a key role in the formation of abnormal blood vessels in the eye. Ranibizumab is classified as an anti-VEGF agent and is designed to improve vision by reducing the growth of these abnormal blood vessels.

Investigated diseases

Neovascular age-related macular degeneration (nAMD) – This is a chronic eye condition that affects the macula, the central part of the retina responsible for sharp vision. It occurs when abnormal blood vessels grow under the retina and macula, leading to leakage of blood and fluid. This leakage can cause the macula to lift from its normal position, resulting in rapid and severe vision loss. The disease typically progresses with symptoms such as blurred or distorted vision, and dark spots in the central vision. Over time, if untreated, it can lead to significant vision impairment. The progression of nAMD can vary, with some individuals experiencing a slow decline in vision, while others may notice a rapid deterioration.