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RekryteringFAS2INTERVENTIONELL

A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

This study is looking into a new treatment called FWY003 for people with Geographic Atrophy (GA), a serious and advanced form of Age-related Macular Degeneration (AMD). Our main goal is to understand what dose of FWY003 works best and is safest. Participants will be randomly assigned to receive either FWY003 or a placebo, which looks like the real medicine but contains no active ingredient. This is a "double-masked" study, meaning neither you nor your doctor will know which treatment you are receiving until the study is over. We will also be carefully monitoring for any side effects. By taking part, you could help us find new ways to treat this condition.

Överblick

Status
Rekrytering
Fas
FAS2
Sponsor
Novartis Läkemedel
Inskrivningsmål
272
Starta
09 mars 2026
Beräknad slutförande
22 Aug 2029

Vad handlar denna studie om?

This research study is about a new investigational medicine, called FWY003, for an eye condition called Geographic Atrophy (GA). GA is a more advanced form of Age-related Macular Degeneration (AMD), which is a common cause of vision loss in older people. In GA, there are patches of severe thinning or damage to the light-sensing cells in the central part of your eye, called the macula, which is responsible for sharp, detailed vision needed for reading and recognising faces.

The main purpose of this study is to learn more about FWY003. We want to find out how effective different doses of FWY003 are at treating GA and if these doses are safe. To do this, some participants will receive FWY003, while others will receive a 'placebo'. A placebo looks exactly like the study medicine but doesn't contain any active drug. This helps us understand if any improvements seen are truly due to FWY003 or something else.

This is a 'randomised, multi-centre, double-masked' study. 'Randomised' means that whether you get FWY003 or the placebo is decided by chance, like flipping a coin. 'Multi-centre' means the study is happening in several different hospitals or clinics. 'Double-masked' means neither you nor your study doctor will know which treatment you are receiving until the study has finished. This helps to make sure the results are fair and unbiased. Your participation could contribute significantly to our understanding of GA and potential new treatments.

Viktiga punkter

  • Tests a new medicine, FWY003, for Geographic Atrophy (GA).
  • Compares FWY003 to a dummy medicine (placebo).
  • Aims to find the best dose and check safety.
  • Neither you nor the doctor will know what treatment you get.
  • Deltagande är frivilligt och du kan dra dig ur när som helst.

Vem kan vara berättigad?

To be considered for this study, you need to be at least 50 years old. You must have a diagnosis of Geographic Atrophy (GA) due to Age-related Macular Degeneration (AMD) in at least one eye, which we call the 'study eye'. The area of GA in your study eye needs to be within certain size limits, and your vision in that eye must also be at a specific level.

There are also some reasons why you might not be able to join. For example, if you have another eye condition like "wet" AMD in either eye, or if you've had certain eye surgeries or cell/gene therapies in either eye recently. Also, if your vision loss is due to something other than AMD, or if you have other eye problems that would make it hard for doctors to examine your eye properly, you likely wouldn't be able to take part.

Your study doctor will go through all the specific requirements with you to see if this study is a good fit. It's important to remember these rules are in place to ensure the study is safe and that the results are clear.

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. Have you been diagnosed with Geographic Atrophy (GA) due to AMD in at least one eye?
  3. Do you *not* have 'wet' AMD in either eye?
  4. Have you *not* had recent eye surgery or cell/gene therapy in your study eye?
  5. Is your vision good enough in the study eye as per your doctor's assessment?
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

If you decide to participate in this study, you would visit the clinic regularly for check-ups and treatments. These visits will include various eye tests, such as vision checks and special scans of your eye, to monitor your condition and how the treatment is affecting it. You will receive either the study medication (FWY003) or a placebo, which will be given in a way determined by the study plan. You won't know which one you are getting. Throughout the study, the research team will keep a close eye on your health and any changes in your vision. The total length of your participation, including all follow-up appointments, will be clearly explained to you by the study team before you make a decision.

Potentiella risker och fördelar

While participating, you might experience potential benefits, such as very close monitoring of your eye health and access to a potential new treatment not yet widely available. However, there are also potential risks, including side effects from the study medication or the procedures involved. The study medication might not improve your condition, or it could even worsen it. The procedures could cause discomfort. You will be given all the information about possible side effects and risks. Please remember that taking part is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Platser (59)

  • Salehi Retina Institute
    Verifierat postnummer
    Huntington Beach, USA· Rekrytering
  • Retinal Consultants Medical Group Inc
    Verifierat postnummer
    Sacramento, USA· Rekrytering
  • California Retina Consultants
    Verifierat postnummer
    Santa Barbara, USA· Rekrytering
  • Advanced Research LLC
    Verifierat postnummer
    Boynton Beach, United States· Rekrytering
  • Advanced Research LLC
    Verifierat postnummer
    Deerfield Beach, United States· Rekrytering
  • Retina Vitreous Associates of Florida
    Verifierat postnummer
    St. Petersburg, USA· Rekrytering
  • Opthamalic Consultants of Boston
    Verifierat postnummer
    Boston, USA· Rekrytering
  • NJ Retina
    Verifierat postnummer
    Toms River, United States· Rekrytering
  • New York Eye and Ear Infirmary of Mount Sinai
    Verifierat postnummer
    New York, USA· Rekrytering
  • Columbia University Medical Center
    Verifierat postnummer
    New York, USA· Rekrytering
  • Erie Retina Research LLC
    Verifierat postnummer
    Erie, United States· Rekrytering
  • Mid Atlantic Retina
    Verifierat postnummer
    Philadelphia, USA· Rekrytering

Vanliga frågor

What is Geographic Atrophy (GA)?

GA is an advanced form of Age-related Macular Degeneration (AMD) where parts of the macula, the central part of your retina, become very thin and damaged, leading to loss of sharp vision.

Vad är en 'placebo'?

A placebo is a dummy treatment that looks exactly like the study medicine but contains no active drug. It helps researchers understand if the real medicine is truly effective.

Kommer jag att veta om jag får den riktiga medicinen eller placebo?

No, in this 'double-masked' study, neither you nor your study doctor will know which treatment you are receiving until the study is over.

Varför är denna studie viktig?

This study aims to find out if FWY003 can be an effective and safe treatment for Geographic Atrophy, which currently has limited treatment options. Your participation could help others in the future.

Can I leave the study once I've started?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your medical care.

Hur du får reda på mer

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