Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
This research study is looking at a new treatment called 4D-150 for wet age-related macular degeneration (nAMD). This condition causes blurry vision and can get worse over time. Current treatments often involve frequent eye injections. This study aims to see if a single injection of 4D-150 can work as effectively as, or better than, the standard treatment, Eylea, which requires more regular injections. Researchers want to find out if this new treatment can help improve or keep your vision stable. The study is comparing 4D-150 to Eylea in adults aged 50 and over. It's a 'double-masked' study, meaning neither you nor your doctor will know which treatment you are receiving, to make the results as fair as possible.
Överblick
Vad handlar denna studie om?
This study is for adults who have a type of eye condition called wet age-related macular degeneration, often shortened to nAMD. This is a common cause of vision loss, especially in older people. In nAMD, abnormal blood vessels grow under the retina (the light-sensing part at the back of your eye), which can leak fluid and blood, causing blurred or distorted vision.
Currently, people with nAMD often need regular injections into their eye to help control the condition and protect their vision. These injections can be frequent, which can be a burden for patients. This study is testing a new treatment called 4D-150. The hope is that 4D-150 might offer a longer-lasting effect, potentially reducing the number of injections needed compared to current treatments.
The study will compare this new treatment (4D-150) with a widely used and effective standard treatment called Eylea (aflibercept). The main goal is to find out if 4D-150 can help improve or maintain vision in people with nAMD as well as, or better than, Eylea, with the potential benefit of fewer injections over time.
Viktiga punkter
- This study is for adults aged 50+ with wet macular degeneration.
- It's testing a new single-injection treatment, 4D-150, against current standard treatment (Eylea).
- The aim is to find a longer-lasting treatment that could reduce the number of eye injections needed.
- Participation involves regular eye check-ups and vision tests.
- You won't know which treatment you receive to ensure fair results.
Vem kan vara berättigad?
To join this study, you generally need to be 50 years old or older and have wet age-related macular degeneration (nAMD) in at least one eye. Your nAMD should be 'active,' meaning there are signs of fluid or leakage that doctors can see with special eye scans. Your vision in the eye being studied also needs to be within a certain range at the start of the study.
It's important that your nAMD is due to age-related macular degeneration and not another eye problem. You can't have certain other serious eye conditions like a history of a detached retina or uncontrolled glaucoma. Also, you shouldn't have had specific previous eye treatments for nAMD, other than a few anti-VEGF injections if you've been treated before. The medical team will carefully check all your eye health details to see if you can take part.
Additionally, you should be in generally good health. If you've had a recent major illness or surgery within the last month, or have uncontrolled high blood pressure, you might not be able to join. The study team will review all your medical history to make sure it's safe for you to participate.
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.
- Are you 50 years old or older with wet macular degeneration?
- Has your wet macular degeneration been diagnosed relatively recently (last 6 months) or have you had very few previous treatments for it?
- Do your doctors see signs of active fluid/leakage in your eye?
- Is your eyesight in the study eye within a specific range, not too good or too bad?
- Are you generally in good health without recent major surgeries or uncontrolled medical conditions?
Vad innebär deltagande?
If you decide to join this study, you'll be assigned by chance to receive either the new treatment (4D-150) or the standard treatment (Eylea). You won't know which one you're getting, and neither will your doctor, which helps keep the study fair. Both treatments are given as a single injection into your eye.
You will need to attend several clinic visits over a period of time. These visits will involve regular eye check-ups, including special eye scans (like OCT scans and photographs) and vision tests, to see how your eyes are responding to the treatment. You'll also have general health checks. The exact number of visits and the total length of the study will be explained in detail by the study team, but typically, studies like this involve follow-up over several months to a couple of years to properly assess the long-term effects.
Potentiella risker och fördelar
Locations (126)
- Research Network ArizonaVerifierat postnummerScottsdale, USA· Aktiv men inte rekryterande
- Barnet Dulaney Perkins Eye CenterVerifierat postnummerSun City, USA· Aktiv men inte rekryterande
- Retina AssociatesVerifierat postnummerTucson, USA· Aktiv men inte rekryterande
- Retinal Diagnostic CenterVerifierat postnummerCampbell, United States· Aktiv men inte rekryterande
- Retina Consultants of Orange CountyVerifierat postnummerFullerton, USA· Aktiv men inte rekryterande
- Northern California Retina Vitreous AssociatesVerifierat postnummerMountain View, USA· Aktiv men inte rekryterande
- Retinal Consultants Medical Group Inc.Verifierat postnummerSacramento, USA· Aktiv men inte rekryterande
- Retinal Consultants Medical GroupVerifierat postnummerSacramento, USA· Aktiv men inte rekryterande
- West Coast Retina Medical GroupVerifierat postnummerSan Francisco, USA· Aktiv men inte rekryterande
- Bay Area Retina AssociatesVerifierat postnummerWalnut Creek, USA· Aktiv men inte rekryterande
- Retina Consultants of Southern Colorado P.C.Verifierat postnummerColorado Springs, USA· Aktiv men inte rekryterande
- Retina Specialists of ColoradoVerifierat postnummerDenver, USA· Aktiv men inte rekryterande
Vanliga frågor
What is 'wet age-related macular degeneration'?
It's a common eye condition where abnormal blood vessels grow in the retina, leaking fluid and blood, which can cause blurry or distorted vision.
What is the new treatment, 4D-150?
It's an investigational treatment given as a single injection into the eye, being tested to see if it can control wet macular degeneration for a longer period than current treatments.
Will I know if I'm getting the new treatment or the standard one?
No, this is a 'double-masked' study, meaning neither you nor your doctors will know which treatment you receive. This ensures the study results are unbiased.
Hur länge kommer jag att vara med i studien?
The study involves a single injection, but you'll have regular follow-up visits over several months to a couple of years to monitor your eye health and the treatment's effects.
Kan jag lämna studien när som helst?
Yes, you are free to leave the study at any point without it affecting your ongoing medical care.
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