A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration
This research is testing a new treatment called SAR402663 for 'wet' age-related macular degeneration (wet AMD), a leading cause of vision loss. The aim is to see if a single injection of this new drug into the eye is safe and effective in improving or keeping patients' vision stable. This is an early-phase study, meaning it's one of the first times this treatment is being tested in people. Participants will be monitored closely for 12 months, with some continuing for up to 5 years to check for long-term safety and how well the treatment lasts. The study will look at different doses to find the most suitable one.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This study is looking into a new treatment, called SAR402663, for a serious eye condition known as 'wet' age-related macular degeneration (wet AMD). Wet AMD can cause blurry vision or blind spots because abnormal blood vessels grow and leak fluid under the retina, which is the light-sensitive tissue at the back of your eye. Current treatments often involve regular injections into the eye, which can be frequent.
Researchers want to see if giving a single dose of SAR402663 directly into the eye is safe and effective. They are hoping this new treatment might offer a longer-lasting solution, potentially reducing the number of injections people need. This is an early-stage study, which means it's about understanding how the drug works, if it's safe, and what dose might be best, rather than being a widely available treatment yet.
The study is divided into two main parts. In the first part, a small number of participants will receive different doses of the treatment to find the safest and most effective amount. In the second part, more participants will be randomly assigned to receive one of two selected doses. Everyone involved — participants, doctors, and those measuring the results — will not know which dose a participant is receiving, to make sure the results are fair and unbiased.
النقاط الرئيسية
- This study is for a new, single-dose eye injection for 'wet' AMD.
- It aims to check if the new treatment, SAR402663, is safe and can help improve or maintain vision.
- Participation involves a single injection and up to 5 years of follow-up appointments.
- You won't know if you get the active drug or a dummy treatment during the study.
- It's an early-stage study, so the benefits and risks are still being understood.
من قد يكون مؤهلاً؟
To join this study, you would generally need to be between 50 and 90 years old and have been diagnosed with 'wet' age-related macular degeneration (AMD). Your study eye should have vision within a certain range to be included, and you must have received anti-VEGF treatments for your wet AMD in the past, and shown some positive response to them.
There are also reasons why someone might not be able to join. For example, if you have another eye condition that could affect your vision or make it hard to assess the treatment, or if you've recently had an eye infection. You also can't have poorly controlled glaucoma, a history of certain eye inflammations, or be currently using steroid eye drops in the study eye. You also can't have received gene therapy in the past, or have other serious health issues that might make it difficult to take part in the study or attend follow-up appointments.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- Are you between 50 and 90 years old?
- Do you have 'wet' age-related macular degeneration (AMD)?
- Have you had previous anti-VEGF treatments for your wet AMD, and did they help?
- Do you have good overall health that would allow you to attend study visits?
- Do you have any eye conditions (other than wet AMD) that might affect your vision or the study results?
- Have you had any recent eye infections or active glaucoma that isn't being controlled?
ماذا يتضمن المشاركة؟
If you decide to take part, you'll receive a single injection of either SAR402663 or a dummy treatment (called a 'diluent') into one eye. This is a blind study, meaning neither you nor your doctors will know which treatment you've received, to ensure accurate results. After the injection, you'll have regular check-ups for 12 months. These check-ups will involve various tests to monitor your eye health and vision, and to see how you're responding to the treatment.
Following these 12 months, some participants will continue into an 'extended follow-up' phase for up to 5 years. During this longer period, the main goal will be to monitor the treatment's safety and see how long any potential benefits last. The total duration of your participation could therefore be up to 5 years, with more frequent visits in the first year.
المخاطر والفوائد المحتملة
المواقع (26)
- Associated Retina Consultants - Phoenix- Site Number : 8400011الرمز البريدي المؤكدفينيكس، الولايات المتحدة
- Retina Macula Institute of Arizona- Site Number : 8400028الرمز البريدي المؤكدسكوتسديل، الولايات المتحدة
- California Retina Consultants - Bakersfield- Site Number : 8400001الرمز البريدي المؤكدبيكرسفيلد، الولايات المتحدة
- Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400023الرمز البريدي المؤكدبيفرلي هيلز، الولايات المتحدة
- Vitreo Retinal Associates - Gainesville- Site Number : 8400004الرمز البريدي المؤكدغينزفيل، الولايات المتحدة
- Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002الرمز البريدي المؤكدسانت بطرسبرغ، الولايات المتحدة
- Southeast Retina Center- Site Number : 8400010الرمز البريدي المؤكدأوغوستا، الولايات المتحدة
- University Retina - Lemont- Site Number : 8400005الرمز البريدي المؤكدLemont, United States
- Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003الرمز البريدي المؤكدHagerstown, United States
- Retina Specialist- Site Number : 8400020الرمز البريدي المؤكدتاوسون، الولايات المتحدة
- Ophthalmic Consultants of Boston - Boston- Site Number : 8400009الرمز البريدي المؤكدبوسطن، الولايات المتحدة
- Sierra Eye Associates- Site Number : 8400021الرمز البريدي المؤكدرينو، الولايات المتحدة
أسئلة شائعة
What is 'wet' age-related macular degeneration (AMD)?
It's an eye condition where abnormal blood vessels grow and leak fluid under the retina, causing blurred vision or blind spots.
What is SAR402663 and how is it given?
SAR402663 is a new experimental drug, given as a single injection into the eye.
Will I know if I'm getting the real drug or a dummy treatment?
No, this is a 'blind' study, so neither you nor your doctors will know which you receive. This helps get fair results.
ما هي المدة التي سأكون مشاركًا فيها في الدراسة؟
You'll have regular check-ups for 12 months, and some participants might continue for up to 5 years to monitor long-term effects.
هل يمكنني مغادرة الدراسة إذا غيرت رأيي؟
Yes, you can choose to leave the study at any time, and this will not affect your future medical care.
كيفية معرفة المزيد
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
نقاش
مناقشة المجتمع
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