Not recruiting

Study on the Use of SB11 Pre-Filled Syringe for Patients with Wet Age-Related Macular Degeneration, Macular Edema from Retinal Vein Occlusion, or Myopic Choroidal Neovascularization

Fast replyRegistered 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 usability of a new treatment method for eye conditions such as Neovascular Age-Related Macular Degeneration (AMD), Macular Edema Secondary to Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). The treatment being tested is a solution for injection called Byooviz, which contains the active substance ranibizumab. This study aims to evaluate how well healthcare professionals can use a pre-filled syringe to administer this treatment directly into the eye.

The study involves a single group of participants who will receive a one-time dose of the treatment. Healthcare professionals will follow specific instructions to prepare and give the injection. The main goal is to see how effectively these instructions can be followed. Participants will be monitored for any side effects or changes in their vision over a short period, typically up to a week after the injection.

Throughout the study, the focus will be on the ease of use of the pre-filled syringe and the safety of the treatment. The study will also look at any improvements in vision that may occur after the injection. This research is important for understanding how this new method of delivering ranibizumab can be used in treating these eye conditions effectively and safely.

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
Joining the study
Upon joining the study, the participant will have already signed an informed consent form. This form confirms understanding of the study and agreement to participate.
The participant must be at least 18 years old and have a condition such as neovascular age-related macular degeneration (AMD), macular oedema secondary to retinal vein occlusion (RVO), or myopic choroidal neovascularization (mCNV) in the study eye.
Step 2
Preparation for treatment
The healthcare professional will prepare the pre-filled syringe (PFS) containing the medication ranibizumab for injection.
The participant will be informed about the procedure and what to expect during the injection process.
Step 3
Administration of medication
The healthcare professional will administer the medication through an intravitreal injection, which means the injection is given directly into the eye.
This is a single-dose procedure, and the participant will receive Byooviz 10 mg/ml solution for injection.
Step 4
Post-injection observation
After the injection, the participant will be observed for any immediate reactions or side effects.
The healthcare professional will ensure the participant is comfortable and provide any necessary care.
Step 5
Follow-up and monitoring
The participant will be monitored for 7 days following the injection to assess any adverse events or changes in vision.
A follow-up visit will be scheduled to evaluate the participant's condition and the effectiveness of the treatment.

Who can join the trial?

6 criteria

The study is for people with one of the following conditions in the study eye: Neovascular Age-Related Macular Degeneration (AMD), Macular Oedema (swelling) due to Retinal Vein Occlusion (RVO), or Myopic Choroidal Neovascularization (mCNV).
The study eye must be suitable for treatment with ranibizumab intravitreal (IVT) therapy, as decided by an eye doctor (such as a retina specialist).
Participants must be aged 18 years or older at the time of signing the informed consent form.
A written informed consent form (ICF) must be signed by the participant before any study-related procedures. If the participant cannot read the form, an impartial witness will be present during the consent discussion.
Participants must be willing and able to attend all scheduled visits and assessments.
Female participants who cannot have children (due to medical conditions or surgeries) or are postmenopausal (no menstrual periods for at least 12 months without another medical reason) can participate. Female participants who can have children or male participants with partners who can have children must agree to use at least two forms of birth control or one highly effective method (such as abstinence) from the start of the study until three months after the injection. If a male participant or their partner has had a vasectomy (a procedure to prevent pregnancy), it must be medically confirmed.

Who cannot join the trial?

8 criteria

Patients with any other eye diseases that could affect the study results.
Patients who have had eye surgery within the last 3 months.
Patients who are currently receiving or have received any other treatment for their eye condition within the last 3 months.
Patients with a history of severe allergic reactions to any of the study medications.
Patients with uncontrolled high blood pressure.
Patients with any serious health conditions that could interfere with the study.
Women who are pregnant or breastfeeding.
Patients who are participating in another clinical trial.

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Gabinet Okulistyczny prof. Edward Wylęgała
Responsive
Katowice, Poland

Trial locations

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Investigated drugs

SB11 is a medication used in this clinical trial to help treat certain eye conditions. It is given as an injection directly into the eye. The main goal of using this medication in the study is to see how well healthcare professionals can follow instructions to prepare and give the injection. This medication is being tested for its use in people with eye problems like Neovascular Age-Related Macular Degeneration, Macular Oedema due to Retinal Vein Occlusion, or Myopic Choroidal Neovascularization. These conditions can cause vision problems, and the medication aims to help manage these issues by being administered directly where it is needed in the eye.

Ranibizumab

What is already known about the treatment

SB11 – SB11 is administered as an intravitreal injection, meaning it is injected directly into the eye using a pre-filled syringe. This medication is currently being studied in clinical trials to evaluate its usability for treating eye conditions. It is primarily used for conditions like Neovascular Age-Related Macular Degeneration (AMD), Macular Oedema Secondary to Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). SB11 works by targeting specific proteins in the eye that contribute to abnormal blood vessel growth and leakage, helping to reduce swelling and improve vision. It is classified as an anti-VEGF (vascular endothelial growth factor) agent, which is a type of medication that inhibits the growth of new blood vessels.

Investigated diseases

Neovascular Age-Related Macular Degeneration (AMD)
This disease affects the central part of the retina, known as the macula, leading to vision loss. It occurs when abnormal blood vessels grow under the retina and macula, causing leakage of blood and fluid. This leakage damages the macula, resulting in blurred or distorted central vision. Over time, the damage can lead to a loss of central vision, making it difficult to see fine details. The progression can vary, with some individuals experiencing rapid changes in vision. It primarily affects older adults and is a leading cause of vision impairment in this age group.
Macular Oedema Secondary to Retinal Vein Occlusion (RVO)
This condition arises when a blockage occurs in the veins carrying blood away from the retina, leading to fluid accumulation in the macula. The fluid buildup causes the macula to swell, resulting in blurred or distorted vision. The swelling can persist, affecting the ability to see fine details and colors. The condition can develop suddenly and may affect one or both eyes. The severity and progression can vary, with some individuals experiencing significant vision changes. It is often associated with other health conditions like hypertension or diabetes.
Myopic Choroidal Neovascularization (mCNV)
This disease is associated with severe myopia, where new, abnormal blood vessels grow under the retina. These vessels can leak blood and fluid, leading to damage in the central retina, known as the macula. The damage results in blurred or distorted central vision, affecting the ability to read or recognize faces. The condition can progress rapidly, causing significant vision changes. It primarily affects individuals with high levels of nearsightedness. The progression and severity can vary, with some experiencing more rapid vision loss than others.