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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.

Överblick

Status
Aktiv men inte rekryterande
Fas
FAS2
Sponsor
Novartis Läkemedel
Inskrivningsmål
168
Starta
17 Feb 2022
Beräknad slutförande
30 sep 2026

Vad handlar denna studie om?

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.

Viktiga punkter

  • 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.

Vem kan vara berättigad?

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.

Kan denna studie passa dig?

Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.

  1. Är du 50 år eller äldre?
  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?
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

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.

Potentiella risker och fördelar

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.

Platser (28)

  • Retina Consultants of Orange County
    Verifierat postnummer
    Fullerton, USA
  • Salehi Retina Institute
    Verifierat postnummer
    Huntington Beach, USA
  • Martel Eye Medical Group
    Verifierat postnummer
    Rancho Cordova, United States
  • Retinal Consultants Medical Group Inc
    Verifierat postnummer
    Sacramento, USA
  • California Retina Consultants
    Verifierat postnummer
    Santa Barbara, USA
  • Southwest Retina Research Center
    Verifierat postnummer
    Durango, United States
  • Advanced Research LLC
    Verifierat postnummer
    Deerfield Beach, United States
  • Retina Center Of South Florida
    Verifierat postnummer
    Delray Beach, USA
  • Retina Vitreous Associates of Florida
    Verifierat postnummer
    St. Petersburg, USA
  • Midwest Eye Institute
    Verifierat postnummer
    Carmel, United States
  • Retina Associates New Orleans
    Verifierat postnummer
    Metairie, USA
  • Retina Care Center
    Verifierat postnummer
    Baltimore, USA

Vanliga frågor

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.

Vad är en '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.

Kommer jag att veta om jag får den riktiga medicinen eller 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.

Hur du får reda på mer

Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.

Diskussion

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