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Study on Long-Term Safety of Ranibizumab for Patients with Wet Age-Related Macular Degeneration Using a Port Delivery 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 the long-term safety and tolerability of a treatment for Neovascular Age-Related Macular Degeneration (nAMD), a condition that affects the eyes and can lead to vision loss. The treatment being studied involves the use of a medication called Ranibizumab, which is delivered through a special device known as the Port Delivery System. This system allows the medication to be released into the eye over an extended period, potentially reducing the need for frequent injections.

The purpose of the study is to evaluate how safe and well-tolerated this method of delivering Ranibizumab is for patients with nAMD. Participants in the study will receive the treatment every 24 or 36 weeks, depending on the specific group they are assigned to. The study will monitor participants over a long period to gather information on any side effects or issues that may arise from the treatment. This will help researchers understand the potential benefits and risks associated with using the Port Delivery System for managing nAMD.

Throughout the study, participants will undergo regular check-ups to assess their vision and overall eye health. These assessments will help determine any changes in vision and identify any adverse effects related to the treatment. The study aims to provide valuable insights into the long-term use of the Port Delivery System with Ranibizumab for individuals with Neovascular Age-Related Macular Degeneration.

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 implantation
The study involves the use of a device called the Port Delivery System with ranibizumab. This device is implanted in the eye to deliver medication over time.
The medication used is ranibizumab, which is a solution for injection. It is administered through implantation.
Step 2
Medication administration
The Port Delivery System releases ranibizumab at a concentration of 100 mg/mL.
The medication is delivered every 24 weeks or every 36 weeks, depending on the specific requirements of the study.
Step 3
Follow-up visits
Regular follow-up visits are scheduled to monitor the safety and tolerability of the treatment.
These visits include assessments of visual acuity and any potential side effects.
Step 4
Monitoring for adverse events
The study monitors for any adverse events, both ocular (related to the eye) and systemic (affecting the rest of the body).
Special attention is given to any adverse events of special interest, particularly during the postoperative period and the follow-up period.
Step 5
Visual acuity assessments
Visual acuity is assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.
The study tracks changes in visual acuity over time, including the percentage of patients who experience specific changes in their vision.
Step 6
Study duration
The study is expected to continue until December 31, 2029.
Participants are monitored throughout the study to ensure the long-term safety and effectiveness of the treatment.

Who can join the trial?

3 criteria

The patient must have previously participated in and completed either Study GX28228 (Ladder) or Study GR40548 (Archway) without stopping early or needing early treatment. This includes those who received monthly eye injections of **ranibizumab** (a medication used to treat certain eye conditions) or had an implant. Alternatively, the patient could have been part of Study WR42221 (Velodrome) and either not been eligible for randomization at Week 24 or completed the study.
The patient must be able and willing to attend all scheduled visits and assessments.
If the patient is a woman who can have children, she must agree to either not engage in heterosexual intercourse or use birth control methods during the treatment period. This should continue for at least 3 months after the last eye injection of **ranibizumab** or 1 year after the last implant refill or exchange of **ranibizumab**.

Who cannot join the trial?

9 criteria

Patients who have any other eye diseases that could affect the study results.
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 serious illness that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have a condition that makes it difficult to follow the study procedures.

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Verified sites

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

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

Trial locations

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Investigated drugs

Ranibizumab is a medication used to treat neovascular age-related macular degeneration, a condition that can lead to vision loss. In this clinical trial, 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 aims to assess how safe and tolerable this method of delivery is for patients over a long period.

Ranibizumab

What is already known about the treatment

Ranibizumab – This medication is administered through a specialized device known as the Port Delivery System, which is implanted in the eye to release the drug over an extended period. It is currently being studied in clinical trials for its long-term safety and tolerability in treating neovascular age-related macular degeneration (nAMD). Ranibizumab is primarily used to treat this eye condition by inhibiting a protein called vascular endothelial growth factor (VEGF), which contributes to the formation of abnormal blood vessels in the eye. It belongs to the pharmacological class of anti-VEGF agents, which are designed to prevent vision loss by reducing the growth of these harmful 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 vision, dark spots in the center of vision, and distorted vision. Over time, if untreated, it can lead to significant central vision impairment, although peripheral vision usually remains unaffected. The progression of nAMD can vary, with some individuals experiencing a slow decline in vision, while others may notice a rapid deterioration.