Why is this study important?
When you’re living with open-angle glaucoma, managing your condition can take up a lot of your time. You have medications to take daily, doctor’s instructions to follow, and frequent appointments to talk with your doctor about your vision. Even though you do these things and more, it may not be enough.
Your vision can still get worse despite proper management of your glaucoma. There are medications available to you, but these can require frequent dosing or may not be effective at slowing or preventing vision loss.
Because you and other glaucoma patients share the same experience, doctors with this research study are evaluating an investigational drug for open-angle glaucoma. They want to learn more about the safety and effectiveness of the investigational drug when it is injected into the eye.
In this study, the investigational drug will be compared to a sham injection, which is a procedure that simulates an injection but does not go into the eye. The investigational drug has not been approved to treat open-angle glaucoma, and it is only available to glaucoma patients in research studies like this one.
The results of this study will provide more information about the investigational drug and whether it could one day be given to people who have open-angle glaucoma.
Who is eligible to take part in this study?
To pre-qualify for this study, you must:
- Be 18 years of age or older
- Have been diagnosed with open-angle glaucoma that is getting worse
Additional criteria will apply. All treatment, tests and medical care required as part of the research study will be provided to you free of charge. In addition, you may be reimbursed for actual costs that you incur as a direct result of your participation in the study (such as travel, parking, meals/refreshments and other expenses).
What will happen during this study?
If you are eligible and agree to participate, you will be randomly assigned (by chance) to receive injections of the investigational drug into your eye or sham injections. You have an 80% (4 in 5) chance of receiving the investigational drug injections or a 20% (1 in 5) chance of receiving sham injections.
You will not be told if you are receiving the investigational drug or sham injections. However, the study doctor will know which treatment you receive.
You will receive 2 injections (investigational drug or sham) in this study, 90 days apart, which will be given at the study clinic. Your total study participation will last approximately 39 weeks (9 months), which includes about 9 study clinic visits for tests and evaluations of your vision and general health.
What are the benefits and risks related to this study?
It’s possible you could receive some benefit from participating in this study, but that is not guaranteed. However, your participation may help people with open-angle glaucoma in the future.
You may also experience one or more side effects while you’re in this study. Prior to beginning this study, the study doctor/staff will review all known study-related side effects and risks with you.
Additionally, your health will be closely monitored throughout your study participation.
What is a research study?
Pharmaceutical companies use research studies like this one to learn more about an investigational drug. Research studies are different from regular medical care because the purpose of regular medical care is to treat a disease or condition. The purpose of research studies is to gather information about an investigational drug.
Doctors and regulatory agencies use what they learn from research studies to decide if an investigational drug could one day be approved and made available to the public.
In order to conduct research studies, doctors and researchers need volunteers like you to participate. By participating in this study, you could help advance research for open-angle glaucoma.
This study is being conducted in Melbourne, Sydney and Albury. If you live in one of those areas and you’d like to find out how you could be a part of this research study opportunity, please contact:
Mobile: 0407 651 291