A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Geographic atrophy is an advanced stage of dry age-related macular degeneration (AMD). It causes cells in the retina to waste away, leading to gradual loss of central vision. There are currently very few treatments available to slow it down. This study tests a new medicine called SAR446597. It is given as a single injection into the eye. Researchers want to learn if the medicine is safe and whether it can help protect your remaining sight. The trial is open to people aged 60 or older with geographic atrophy. In the second part of the study, some people will receive a dummy (sham) procedure instead of the active medicine, allowing doctors to make a fair comparison. Taking part involves a two-year main study followed by three years of monitoring, making five years in total. During this time, specialists will regularly check your eyes and vision.
एक नजर में
यह अध्ययन किस बारे में है?
Age-related macular degeneration (AMD) is a common eye condition affecting the macula, the part of the eye responsible for sharp central vision. In its advanced dry stage, called geographic atrophy, patches of cells at the back of the eye slowly break down and disappear. Over time, this causes blind spots and makes everyday tasks like reading, cooking, or recognising faces much harder. At present, treatment options remain very limited.
This clinical trial is testing an experimental medicine named SAR446597. The treatment is designed to be given just once as an injection directly into the jelly-like fluid of the eye (an intravitreal injection). Doctors hope this single treatment will protect retinal cells from further damage and slow down the spread of geographic atrophy.
The study has two phases. The first phase tests different doses to ensure the medicine is safe and well tolerated. The second phase compares the medicine against a 'sham' (dummy) procedure to see how well it actually works at slowing disease progression. By tracking participants over several years, researchers hope to see if this treatment can offer lasting protection for eyesight.
मुख्य निष्कर्ष
- Tests an experimental one-off eye injection for geographic atrophy (advanced dry AMD).
- Open to adults aged 60 and over who meet specific eye measurements.
- Aims to find out if the treatment is safe and can slow down the loss of central sight.
- Involves one treatment followed by regular eye checks over five years in total.
- Some participants will receive a dummy (sham) procedure for comparison purposes.
कौन पात्र हो सकता है?
You may be able to join this study if you are 60 years old or older and have geographic atrophy caused by dry AMD. The study team will measure your vision and take detailed pictures of the back of your eye to make sure the damaged area meets the trial's exact size requirements.
You will not be eligible if your vision problems are caused by another eye condition or by 'wet' AMD, which involves leaking blood vessels. People who have had injections for wet AMD in the study eye cannot take part.
You will also be excluded if you have had a recent eye infection, uncontrolled glaucoma, eye inflammation such as uveitis, or certain prior treatments like eye steroids, laser therapy to the macula, or gene therapy. A trial doctor will carefully review your full medical history to confirm if joining is safe for you.
क्या यह अध्ययन आपके लिए उपयुक्त हो सकता है?
यह देखने के लिए इन त्वरित प्रश्नों का उत्तर दें कि क्या आप पात्र हो सकते हैं। यह केवल एक मार्गदर्शिका है — अंतिम निर्णय शोध टीम द्वारा लिया जाता है।.
- I am aged 60 or older.
- I have been diagnosed with geographic atrophy caused by dry AMD.
- I have never been treated for wet AMD in the study eye.
- I have not had an eye infection or steroid treatment in the eye recently.
- I am willing and able to attend hospital appointments for up to five years.
भागीदारी में क्या शामिल है?
If you take part, you will receive a single treatment in the study eye. Depending on which group you are in, this will either be the active medicine or a 'sham' procedure. A sham procedure mimics an injection by applying light pressure to the eye, but no needle goes into the eye and no medicine is given.
The main study lasts around two years, followed by an extended follow-up phase of three years, making five years in total. You will need to attend regular clinic appointments so the medical team can test your vision, take detailed scans of your retina, and check your overall health. These frequent visits help doctors spot any side effects early and see how your eye responds over time.
संभावित जोखिम और लाभ
Locations (35)
- Associated Retina Consultants - Peoria- Site Number : 8400011सत्यापित पोस्टकोडपियोरिया, संयुक्त राज्य अमेरिका· भर्ती
- Retina Macula Institute of Arizona- Site Number : 8400028सत्यापित पोस्टकोडस्कॉट्सडेल, संयुक्त राज्य अमेरिका· भर्ती
- Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400033सत्यापित पोस्टकोडबेवर्ली हिल्स, संयुक्त राज्य अमेरिका· भर्ती
- The Retina Partners- Site Number : 8400040सत्यापित पोस्टकोडएन्सिनो, संयुक्त राज्य अमेरिका· भर्ती
- California Retina Consultants - Oxnard - North Ventura Road- Site Number : 8400014सत्यापित पोस्टकोडOxnard, United States· भर्ती
- Retinal Consultants - Sacramento - Parkcenter Drive- Site Number : 8400054सत्यापित पोस्टकोडसैक्रामेंटो, संयुक्त राज्य अमेरिका· भर्ती
- Macula Retina Vitreous Center - Torrance- Site Number : 8400053सत्यापित पोस्टकोडटोरेंस, संयुक्त राज्य अमेरिका· भर्ती
- Bay Area Retina Associates - Walnut Creek - Lennon Lane- Site Number : 8400039सत्यापित पोस्टकोडवालनट क्रीक, संयुक्त राज्य अमेरिका· भर्ती
- Vitreo Retinal Associates - Gainesville- Site Number : 8400004सत्यापित पोस्टकोडगेन्सविल, संयुक्त राज्य अमेरिका· भर्ती
- Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002सत्यापित पोस्टकोडसेंट पीटर्सबर्ग, संयुक्त राज्य अमेरिका· भर्ती
- East Florida Eye Institute- Site Number : 8400038सत्यापित पोस्टकोडStuart, United States· भर्ती
- Southeast Retina Center- Site Number : 8400044सत्यापित पोस्टकोडऑगस्टा, संयुक्त राज्य अमेरिका· भर्ती
सामान्य प्रश्न
What is a sham injection?
A sham procedure feels like having an injection, but no needle enters your eye and no drug is delivered. It helps researchers fairly judge whether the real medicine is truly working.
Will the injection be painful?
Before any treatment, the doctor uses anaesthetic drops to numb your eye thoroughly. You may feel a slight sensation of pressure, but it should not be painful.
How many times will I need to be treated?
SAR446597 is designed as a one-time treatment. You will only receive the injection (or sham procedure) once during the entire study.
Can I continue seeing my usual optician or eye doctor?
Yes. Taking part does not replace your routine eye care. You should let your regular doctor know you are participating in a clinical trial.
What happens if I decide to leave the study early?
Joining is completely voluntary. You can choose to leave the study at any time for any reason, and your regular eye care will continue as normal.
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