What is the SIENNA clinical research study?
If you were diagnosed with GA, please know that you are not alone in your medical journey.
Currently, we are working on developing potential treatments for GA. The SIENNA study is a phase 3 clinical research study that aims to evaluate how safe and effective the study drugs alone or in combination are in slowing the progression of GA.
What are the study treatments?
Investigational treatment: The investigational treatments will be administered by subcutaneous injection (a needle under the skin).
Placebo: A placebo looks like a treatment but does not contain any real medicine and will also be administered by subcutaneous injection (a needle under the skin).
Researchers can tell whether an investigational treatment is effective by understanding if it works better than a placebo.
Once the study doctor confirms that you qualify, you will be assigned to 1 of 3 treatment groups. You will either receive a combination of the two investigational study drugs, the second investigational study drug alone plus a placebo, or two placebo doses. You will have an equal chance (1 in 3 or about 33% chance) of receiving any one of these treatment combinations.
This trial is double-masked. This means that neither you nor the study doctor or the staff will know which treatment you are receiving. The study doctor or staff can be told what you received if there is an emergency.
What can I expect if I participate?
Study participation is 100% voluntary (your choice). You will receive information on what to expect, as well as your roles and responsibilities if you join the GA study. You may leave the study at any time without it affecting your regular health care.
If you join the study, there are certain things you will be expected to do. This includes attending study visits and undergoing certain assessments and procedures, including eye exams, blood draws, vaccinations, and unplanned visits. Your participation may last up to 154 weeks (just under 3 years)* with 32 study visits without the optional treatment extension period.
* Note: At the end of the study, participants who have completed the week 104 visit and who have not discontinued treatment will have the option to enter the extension period where active treatment (without placebo) will be received for up to 3 years before proceeding to the post-treatment period. After treatment ends, participants will be followed for about 36 weeks. If they choose this option, total participation could last up to about 6 years.
Qualified participants will receive medical care related to their participation, including the study treatment, at no cost. Some of the medical care given during this study is the usual care a doctor would recommend for this condition even if you were not in the study. You or your health insurance will have to pay for this usual medical care, and also for medications, tests, and supplies that are not required as part of the study. The study team will discuss all of this with you.
How can I take part?
If you wish to take part in the SIENNA study, you can fill in a short pre-screener questionnaire to see if you may be eligible.
Am I eligible?
What can I expect if I participate?
As with all medicines, there are possible risks when taking the investigational treatment. If you qualify and choose to participate, you will be provided with an Informed Consent Form that explains any possible risks and side effects. It is also possible that the study treatments may affect you in unknown ways. Your health and safety are our top priorities and will be closely monitored throughout your participation.
There is no guarantee that you will receive a medical benefit from participating in this study. Your condition may get better, stay the same, or may even get worse. You are free to withdraw from the study for any reason and at any time.
Please note that this clinical trial will use investigational drug products, the safety and efficacy of which has not been fully evaluated by Regulatory Authorities. One of the investigational drug products has been approved for certain uses in some countries. Please consult with the study physician for more information.
Find a study site near you
To find out more about the SIENNA study, and whether it may be right for you, please contact your closest study site – they will be more than happy to help.
Find your nearest study site
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