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ReclutamientoConfirmatorio terapéutico (Fase III)Intervencionista

A Phase 3 Clinical Trial to Compare Efficacy, Safety, Tolerability and Immunogenicity of RBS-001 to Eylea® in Subjects with Neovascular Age-Related Macular Degeneration

This research study is about finding new and better ways to treat a common eye condition called wet age-related macular degeneration, or wet AMD. This condition can cause blurry vision or blind spots. We are testing a new medicine called RBS-001 and comparing it to a treatment that is already used, called Eylea. For this study, we'll be looking at how well RBS-001 helps improve your eyesight over time compared to Eylea. We'll also be carefully checking for any side effects and how well your body tolerates the new medicine. This is a large study (Phase 3), meaning it's one of the final steps before a new treatment might become widely available.

De un vistazo

Estado
Reclutamiento
Fase
Confirmatorio terapéutico (Fase III)
Patrocinador
Rophibio Inc.
Objetivo de inscripción
289
Inicio
07 May 2024

¿De qué trata este estudio?

This research project is designed to investigate a new medication, RBS-001, as a potential treatment for wet age-related macular degeneration (wet AMD). Wet AMD is a common eye condition that affects the macula, the part of your eye responsible for sharp, central vision, which you use for tasks like reading and recognising faces. In wet AMD, unwanted blood vessels grow under the macula, leaking fluid and blood, which can distort vision and lead to blind spots.

The main goal of this study is to compare RBS-001 with Eylea, a medication currently used to treat wet AMD. We want to see if RBS-001 is as effective, or even more effective, at improving and preserving your eyesight. We'll also be carefully monitoring how safe the new medication is and whether participants experience any side effects. This is a 'Phase 3' study, which means it’s a later stage of research involving a larger number of people, and the results from studies like this are very important for deciding if a new medicine should be approved for general use.

Throughout the study, we will be regularly checking your vision using a standard eye chart. We'll also use special eye scans, like OCT (Optical Coherence Tomography) and FA (Fluorescein Angiography), to look at the back of your eye, monitoring things like fluid build-up and the abnormal blood vessels. All these tests help us understand how well the treatments are working and track any changes in your eye health.

Puntos clave

  • This study is testing a new eye medicine, RBS-001, for wet AMD.
  • It compares the new medicine to an existing treatment called Eylea.
  • The main aim is to see if RBS-001 improves vision and is safe.
  • Participants will have regular eye injections and many eye checks.
  • The study lasts about one year and involves people aged 18 and over.

¿Quién puede ser elegible?

To be able to join this study, generally, you would need to be 18 years old or older. The study is open to both men and women.

Important requirements for joining also include having been diagnosed with wet age-related macular degeneration in at least one eye. The doctors will need to check your medical history and perform a full eye exam to make sure you meet all the specific criteria for the study.

There might be other health conditions or medications that would prevent you from taking part, to ensure the study is safe for everyone involved and that the results are clear. Your study doctor will discuss all these details with you.

¿Podría este estudio ser adecuado para ti?

Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.

  1. ¿Tienes 18 años o más?
  2. Have you been diagnosed with wet age-related macular degeneration (wet AMD)?
  3. Are you prepared for regular eye injections?
  4. Can you attend frequent hospital or clinic appointments for about a year?
Responde cada pregunta para ver tu resultado.

¿En qué consiste la participación?

If you decide to take part in this study, you will receive regular injections into your eye, either with the new medicine RBS-001 or with Eylea. These injections are like the ones already used for wet AMD. You will also have many follow-up appointments, especially during the first few months, to check your vision and the health of your eyes.

During these visits, you'll have various eye tests. This includes looking at eye charts to check your sharpness of vision, and eye scans (like OCT and FA) to see what's happening at the back of your eye. You might also have blood tests and general health checks. These visits will continue for up to a year, with the frequency of visits gradually reducing over time. The total duration of your participation in the study will be about 52 weeks (one year).

Riesgos y beneficios potenciales

Taking part in a clinical trial may offer the potential benefit of trying a new treatment that might improve your vision or slow down the progression of your wet AMD. However, like all medications and procedures, there are potential risks, including side effects from the eye injections, such as discomfort, redness, or, in rare cases, more serious eye problems. The new drug, RBS-001, may also have unknown side effects. You will be closely monitored for any adverse reactions throughout the study. Remember, joining this study is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Ubicaciones (4)

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    Bulgaria
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    Croacia
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    Eslovaquia
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    Polonia

Preguntas comunes

What is wet age-related macular degeneration (wet AMD)?

Wet AMD is an eye condition where abnormal blood vessels grow in the back of your eye, leaking fluid and blood, which blurs your central vision.

What is Eylea?

Eylea is a medication already approved and used to treat wet AMD by slowing down the growth of these abnormal blood vessels.

What is a Phase 3 clinical trial?

A Phase 3 trial means the new treatment has already passed earlier safety checks and is now being compared to existing treatments in a larger group of people to confirm its effectiveness and safety.

Will I know if I'm getting RBS-001 or Eylea?

Often in these types of studies, participants don't know which treatment they are receiving (it's called 'blinded') to ensure the results are as fair and accurate as possible.

How long will I need to be in the study?

Your involvement in this study would be for approximately 52 weeks, which is about one year.

Cómo obtener más información

Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.

¿Interesado en participar?

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