A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)
This study, called Velodrome, is for people with 'wet' Age-related Macular Degeneration (nAMD). It's testing a new approach to giving eye medicine called ranibizumab. Instead of frequent injections, the medicine is put into a tiny implant in the eye that can release it over a long period, potentially reducing the need for many clinic visits. The study is comparing how well this implant works when refilled every 36 weeks (about 8 months) versus every 24 weeks (about 5.5 months). Researchers want to check if it's safe and effective, and see how the body uses the medicine over time. Your vision would be closely monitored throughout the study.
At a glance
What is this study about?
This research study is looking for volunteers who have a common eye condition called 'wet' Age-related Macular Degeneration, often shortened to nAMD. This condition affects your central vision, making everyday tasks like reading or recognising faces difficult. Normally, people with nAMD need regular eye injections to help protect their eyesight, which can be frequent and inconvenient.
The Velodrome study is investigating a new way to deliver this medicine. Instead of injections every few weeks, a small, refillable implant is placed in the eye. This implant steadily releases the medicine, called ranibizumab, over a longer period. The idea is that this might mean fewer trips to the eye clinic for injections, making treatment less burden for patients.
Researchers want to see if refilling this implant every 36 weeks (about 8 months) is as good and safe as refilling it every 24 weeks (about 5.5 months). They will be carefully checking participants' vision, overall health, and how the medicine works in their bodies. Your participation would help us understand if this new treatment method could become a good option for people with nAMD in the future.
Key takeaways
- This study evaluates a new treatment method for 'wet' AMD.
- It uses a refillable eye implant to deliver medicine, reducing injection frequency.
- The study compares how often the implant needs refilling: every 24 or 36 weeks.
- It aims to find out if this new method is safe and effective for long-term use.
- Participants must have nAMD and have already had previous successful eye injections.
- Your vision and overall health would be closely monitored throughout the study.
Who may be eligible?
To join this study, you need to be at least 50 years old. You must have been diagnosed with 'wet' Age-related Macular Degeneration (nAMD) within the last nine months and have already had at least three eye injections for nAMD in the past six months, which helped your vision.
There are also some reasons you might not be able to join. For example, if you've had certain eye surgeries or treatments for your AMD in the study eye, or if you've received specific other eye medicines recently. The study also cannot include you if you have other eye conditions that might affect the implant or if the bleeding in your eye is too severe.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 50 years old or older?
- Have you been diagnosed with 'wet' AMD within the last 9 months?
- Have you had at least 3 eye injections for your AMD in the last 6 months that worked well?
- Do you currently have reasonably good vision (better than 20/200 Snellen equivalent)?
What does participation involve?
If you join the study, you'll have regular visits to the clinic where your vision will be checked and the implant in your eye will be refilled with medicine. These visits will help doctors monitor how well the treatment is working and ensure its safety. You'll also have various assessments throughout the study, including eye exams and possibly blood tests. The total duration of your participation in the study is not specified in this summary, but clinical trials typically involve follow-up over several months or even a few years.
Potential risks and benefits
Locations (104)
- Centro Oftalmologico Dr. Charles S.A.UnverifiedCapital Federal, Argentina
- OftalmosUnverifiedCapital Federal, Argentina
- Grupo Laser VisionVerified postcodeRosario, Argentina
- Eyeclinic Albury WodongaVerified postcodeAlbury, Australia
- Eye and Retina ConsultantsVerified postcodeHurstville, Australia
- Retina Associates LiverpoolVerified postcodeLiverpool, Australia
- Retina and Macula SpecialistsVerified postcodeMiranda, Australia
- Sydney Eye HospitalVerified postcodeSydney, Australia
- Sydney Retina Clinic and Day SurgeryVerified postcodeSydney, Australia
- Queensland Eye InstituteVerified postcodeWoolloongabba, Australia
- Centre For Eye Research AustraliaVerified postcodeEast Melbourne, Australia
- Retina Specialists VictoriaVerified postcodeRowville, Australia
Common questions
What is 'wet' Age-related Macular Degeneration (nAMD)?
It's an eye condition that can blur your central vision, making everyday tasks like reading difficult.
What is an eye implant?
It's a tiny device placed in the eye that can steadily release medicine over a long time.
Will I still need eye injections with the implant?
The implant is designed to reduce the need for frequent direct eye injections by slowly releasing medicine.
How often would the implant be refilled?
This study is comparing refilling the implant every 24 weeks (about 5.5 months) versus every 36 weeks (about 8 months).
What happens if I decide to leave the study?
You are free to leave the study at any time, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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