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.
De un vistazo
¿De qué trata este estudio?
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.
Puntos clave
- 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.
- Participation is voluntary and you can withdraw at any time.
¿Quién puede ser elegible?
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.
¿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.
- Are you 50 years old or older?
- Have you been diagnosed with Geographic Atrophy (GA) due to AMD in at least one eye?
- Do you *not* have 'wet' AMD in either eye?
- Have you *not* had recent eye surgery or cell/gene therapy in your study eye?
- Is your vision good enough in the study eye as per your doctor's assessment?
¿En qué consiste la participación?
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.
Riesgos y beneficios potenciales
Locations (59)
- Salehi Retina InstituteCódigo postal verificadoHuntington Beach, United States· Reclutamiento
- Retinal Consultants Medical Group IncCódigo postal verificadoSacramento, United States· Reclutamiento
- California Retina ConsultantsCódigo postal verificadoSanta Barbara, United States· Reclutamiento
- Advanced Research LLCCódigo postal verificadoBoynton Beach, United States· Reclutamiento
- Advanced Research LLCCódigo postal verificadoDeerfield Beach, United States· Reclutamiento
- Retina Vitreous Associates of FloridaCódigo postal verificadoSt. Petersburg, United States· Reclutamiento
- Opthamalic Consultants of BostonCódigo postal verificadoBoston, Estados Unidos· Reclutamiento
- NJ RetinaCódigo postal verificadoToms River, United States· Reclutamiento
- New York Eye and Ear Infirmary of Mount SinaiCódigo postal verificadoNueva York, Estados Unidos· Reclutamiento
- Columbia University Medical CenterCódigo postal verificadoNueva York, Estados Unidos· Reclutamiento
- Erie Retina Research LLCCódigo postal verificadoErie, United States· Reclutamiento
- Mid Atlantic RetinaCódigo postal verificadoFiladelfia, Estados Unidos· Reclutamiento
Preguntas comunes
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.
¿Qué es un '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.
¿Sabré si estoy recibiendo el medicamento real o el 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.
¿Por qué es importante este estudio?
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.
Cómo obtener más información
Novartis Farmacéutica
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.