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Ativo, mas não recrutandoFASE2INTERVENCIONISTA

A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration

This study is investigating a new medication called Iptacopan. The main goal is to find out if this medicine can help prevent worsening of a serious eye condition called age-related macular degeneration, specifically to stop it from turning into a more severe form. Researchers are looking for people who have early or intermediate AMD in one eye, and a different, more advanced type of AMD (called neovascular AMD) in their other eye. Participants will be given either the new medicine or a dummy pill (placebo). This is to see if Iptacopan is safe and effective in slowing down the progression of this eye disease, which is a leading cause of vision loss.

Em resumo

Status
Ativo, mas não recrutando
Fase
FASE2
Patrocinador
Novartis Farmacêutica
Meta de inscrição
168
Iniciar
17 Feb 2022
Conclusão estimada
30 Set 2026

Sobre o que é este estudo?

This research study is focused on a common eye condition called age-related macular degeneration, or AMD. AMD can affect your central vision, making it harder to recognise faces, read, or drive. This study aims to test a new medicine called Iptacopan. The main goal is to see if this medicine can stop or slow down the progression of AMD, especially preventing it from becoming a more advanced and vision-threatening form.

To do this, the study needs people who have a specific combination of AMD. You would need to have early or intermediate-stage AMD in one eye, along with certain warning signs that show on eye scans. In your other eye, you would need to have a more advanced type of AMD called neovascular AMD. This specific combination helps researchers understand how Iptacopan works in different stages of the disease.

Approximately 146 people worldwide will take part. Participants will be randomly assigned to receive either the Iptacopan medicine or a placebo, which looks identical but contains no active medicine. Neither you nor your study doctor will know which you are receiving. This 'masked' approach is standard in research to ensure results are as unbiased as possible. The study will help us learn if Iptacopan can be a future treatment option for AMD.

Pontos principais

  • Exploring a new medicine (Iptacopan) for Age-related Macular Degeneration (AMD).
  • Aims to prevent AMD from worsening into more severe forms.
  • For people aged 50+ with specific AMD types in each eye.
  • Participants will receive either Iptacopan or a placebo.
  • Involves regular visits and detailed eye checks.
  • Participation is voluntary, you can leave at any time.

Quem pode ser elegível?

To join this study, you need to be at least 50 years old. You must have a diagnosis of early or intermediate AMD in one eye, along with specific features visible on eye scans. In your other eye, you must have a diagnosis of a more advanced type of AMD called neovascular AMD.

Before starting the study medicine, you'll need to have certain vaccinations to protect against infections like meningitis and pneumonia. If available and suitable, you should also be vaccinated against Haemophilus influenzae.

There are several reasons why you might not be able to join. These include certain heart conditions, a history of stroke or heart attack in the past six months, kidney failure requiring dialysis or transplant, cancer, organ transplants, or recurrent meningitis. You also can't participate if you have certain infections like HIV, Hepatitis B or C, or if you're allergic to any of the study medicines or similar substances.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  1. Você tem 50 anos ou mais?
  2. Do you have early or intermediate AMD in one eye?
  3. Do you have a more advanced type of AMD (neovascular AMD) in your other eye?
  4. Are you able to get required vaccinations against certain infections?
  5. Do you have any serious heart, kidney, or immune system conditions?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to take part, you'll first have a screening visit to check if you meet all the study requirements. If you're eligible, you'll be randomly assigned to receive either the study medicine, Iptacopan, or a placebo (a dummy pill). Both are taken as oral capsules.

You'll be asked to attend several follow-up visits with the study team. These visits will involve various tests and examinations to check your eye health, general health, and how you are responding to the treatment. They'll also monitor for any side effects. The total length of your participation in the study, including the follow-up, will be determined by the study design, and your study team will give you all the details.

Throughout the study, you'll be closely monitored by medical professionals. It's important to attend all scheduled appointments and report any new symptoms or concerns to the study staff.

Riscos e benefícios potenciais

Potential benefits from taking part in this study include contributing to medical knowledge that could help future patients with AMD, and you might personally benefit if Iptacopan proves effective in slowing your condition's progression. However, there's no guarantee of direct benefit for you. Potential risks are associated with any new medication; these might include side effects from Iptacopan or routine study procedures. The study team will explain all known and potential risks in detail. Remember, participation is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (28)

  • Retina Consultants of Orange County
    Código postal verificado
    Fullerton, Estados Unidos
  • Salehi Retina Institute
    Código postal verificado
    Huntington Beach, Estados Unidos
  • Martel Eye Medical Group
    Código postal verificado
    Rancho Cordova, United States
  • Retinal Consultants Medical Group Inc
    Código postal verificado
    Sacramento, Estados Unidos
  • California Retina Consultants
    Código postal verificado
    Santa Barbara, Estados Unidos
  • Southwest Retina Research Center
    Código postal verificado
    Durango, United States
  • Advanced Research LLC
    Código postal verificado
    Deerfield Beach, United States
  • Retina Center Of South Florida
    Código postal verificado
    Delray Beach, United States
  • Retina Vitreous Associates of Florida
    Código postal verificado
    São Petersburgo, Estados Unidos
  • Midwest Eye Institute
    Código postal verificado
    Carmel, United States
  • Retina Associates New Orleans
    Código postal verificado
    Metairie, Estados Unidos
  • Retina Care Center
    Código postal verificado
    Baltimore, Estados Unidos

Perguntas frequentes

What is Age-related Macular Degeneration (AMD)?

AMD is an eye condition that can blur your central vision, making it hard to see fine details. It usually affects older people.

What is Iptacopan?

Iptacopan is a new medicine being tested in this study to see if it can help slow down the progression of AMD.

O que é um 'placebo'?

A placebo is a 'dummy' pill that looks just like the study medicine but contains no active ingredients. It helps researchers compare the real medicine's effects.

Saberei se estou recebendo o medicamento real ou o placebo?

No, neither you nor your study doctor will know whether you are receiving Iptacopan or the placebo. This is standard practice in clinical trials to ensure fair results.

What are 'high-risk features' on an OCT scan?

These are specific changes seen in detailed eye scans (OCT) of your retina that suggest your AMD might progress more quickly.

Como saber mais

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

Discussão

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