Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
This research study is looking into a new tablet medicine called tinlarebant for people with a common eye condition called Geographic Atrophy (GA). GA causes parts of the retina to waste away, leading to blind spots or blurry vision. The study aims to find out if tinlarebant is safe and effective in slowing down or stopping the progression of GA. Some participants will receive the new medicine, while others will receive a placebo (a dummy pill with no active ingredient) for comparison. The study will last for two years, and participants will take their assigned treatment once a day. This is a vital stage in developing potential new treatments for this challenging eye condition.
At a glance
What is this study about?
This study is a very important step in finding new ways to treat Geographic Atrophy (GA), which is a common and serious eye condition. GA is an advanced form of age-related macular degeneration (AMD) that causes a part of your eye called the macula to slowly waste away. The macula is responsible for your central vision, so its damage can lead to blurry vision, blind spots, or difficulty seeing fine details.
The research is testing a new medicine called tinlarebant. Doctors want to see if this medicine can help to protect the macula and slow down the progression of GA. It's a 'Phase 3' study, which means it's one of the final steps before a new medicine might be approved for general use, if it proves to be safe and effective.
Participants will take a tablet once a day for two years. Some will receive the active medicine, tinlarebant, and others will receive a 'placebo,' which looks the same but contains no medicine. This allows the researchers to fairly compare the effects of the new treatment against doing nothing. All participants will be closely monitored by medical staff throughout the study.
Key takeaways
- This study is testing a new tablet medicine, tinlarebant, for Geographic Atrophy (GA).
- It aims to see if the medicine is safe and can slow down or stop GA progression.
- Participants will take a daily tablet for two years; some will receive the medicine, some a placebo.
- Regular clinic visits will monitor eye health and overall well-being.
- The study is for people aged 60-85 with a GA diagnosis and specific vision criteria.
Who may be eligible?
To join this study, you must have been diagnosed with Geographic Atrophy (GA) in at least one of your eyes. Your vision in the eye being studied needs to meet a certain minimum level.
However, you won't be able to join if you have certain other eye conditions. For example, if you have swelling at the back of your eye due to diabetes, or another serious eye condition that affects blood vessels in your retina. If you have glaucoma, it needs to be well-controlled in the eye being studied.
This study is for adults aged between 60 and 85 years old, and is open to both men and women.
- Have I been diagnosed with Geographic Atrophy (GA) in at least one eye?
- Is my vision in the eye being studied good enough as required by the study?
- Do I have serious diabetic eye problems or other advanced retinal vascular diseases?
- Is my glaucoma, if I have it, well-controlled in the eye being studied?
- Am I between 60 and 85 years old?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be assigned to either receive the new medicine (tinlarebant) or a placebo (a dummy pill) for a period of two years. You won't know which you are receiving, and neither will your study doctor – this helps make the results fair and accurate. You'll take one tablet by mouth every day for the entire two-year period.
Throughout the study, you'll have regular visits to the clinic. During these visits, the study team will carry out various checks and assessments, including eye exams, vision tests, and other medical tests, to see how you're responding to the treatment and to monitor your general health. You'll have follow-up appointments after this two-year period to ensure your safety and monitor your progress.
Potential risks and benefits
Locations (49)
- Belite Study SitePhoenix, United States
- Belite Study SiteArcadia, United States
- Belite Study SiteBeverly Hills, United States
- Belite Study SiteHuntington Beach, United States
- Belite Study SiteLos Angeles, United States
- Belite Study SitePalo Alto, United States
- Belite Study SiteSan Diego, United States
- Belite Study SiteLakeland, United States
- Belite Study SiteHagerstown, United States
- Belite Study SiteSaint Louis Park, United States
- Belite Study SiteWestbury, United States
- Belite Study SiteCary, United States
+37 more sites — see the official record for the full list.
Common questions
What is Geographic Atrophy (GA)?
GA is an advanced form of age-related macular degeneration where the central part of your vision, called the macula, slowly wastes away. This can cause blind spots or blurry vision.
What is a placebo?
A placebo is a 'dummy pill' that looks exactly like the actual medicine but contains no active ingredients. It's used to compare the effects of the real medicine.
How long will the study last?
If you participate, you will take the study medicine for two years, and there will be follow-up appointments after that.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know whether you are receiving the real medicine or the placebo. This is to ensure the study results are fair.
Can I stop participating in the study if I change my mind?
Yes, you are free to withdraw from the study at any time, for any reason, without affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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