A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
This clinical trial is designed to investigate two experimental medications, pozelimab and cemdisiran, for people who have Geographic Atrophy (GA). GA is a more severe form of Age-related Macular Degeneration (AMD), an eye condition that affects your central vision, making it harder to see details straight ahead. The main goal is to find out if these study drugs, either on their own or combined, can slow down the worsening of GA compared to a placebo (an inactive treatment). Researchers are also checking for any side effects, how the drugs move through the body, and if the body develops a reaction to them. This information will help determine if these treatments are safe and effective.
At a glance
What is this study about?
This study is exploring potential new treatments for a serious eye condition called Geographic Atrophy (GA). GA is a late stage of Age-related Macular Degeneration (AMD), which is a common cause of vision loss in older adults. AMD specifically affects your macula, the part of your eye responsible for your clear, central vision – what you use for reading, driving, and recognising faces. In GA, special cells in your macula unfortunately waste away, leading to blind spots and a gradual loss of central vision.
The researchers are testing two new medicines, pozelimab and cemdisiran. They want to see if these drugs can slow down the progression of GA. Some participants will receive one of the study drugs, some will receive both, and others will receive a placebo. A placebo looks like the study drug but contains no active medicine, and it's used to fairly compare the real treatment's effects. The hope is that these new treatments could help preserve vision for people living with GA.
Beyond slowing down the condition, the study will also carefully monitor participants to understand the drugs better. This includes looking for any side effects, how the drugs act in the body, and if the body's immune system reacts to them. This thorough investigation helps ensure that any new treatment is not only effective but also safe for patients.
Key takeaways
- Study is for Geographic Atrophy (GA), a late stage of AMD.
- Investigating new drugs, pozelimab and cemdisiran, for slowing GA progression.
- Compares active treatments to a placebo.
- Includes regular eye exams, blood tests, and drug administration via injection.
- Aims to understand drug effectiveness and safety.
- Participation range: ages 50-85.
Who may be eligible?
To join this study, people generally need to be between 50 and 85 years old. Your eye doctor would need to confirm that you have Geographic Atrophy (GA) in at least one eye due to Age-related Macular Degeneration (AMD). The affected area in your eye must be within a specific size range, and your vision in that eye needs to be at a certain level. You also need to be able to comfortably attend all study appointments and undergo required tests, including getting specific vaccinations.
There are several reasons why someone might not be able to participate. For example, if your GA is caused by something other than AMD, or if you also have another serious eye condition like wet AMD, you wouldn't be eligible. You also can't have had certain other eye treatments or surgeries recently, or have other eye conditions that might interfere with how the study is conducted. The researchers will carefully check for all these criteria to make sure the study is right for you.
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 between 50 and 85 years old?
- Has your eye doctor diagnosed you with Geographic Atrophy (GA) due to AMD?
- Do you have good enough vision in your study eye to meet the requirements?
- Are you able to attend regular clinic visits and undergo required eye tests and vaccinations?
- Do you have any other serious eye conditions like wet AMD or recent eye surgeries (other than cataract removal more than 3 months ago)?
What does participation involve?
If you decide to take part in this study, you will be assigned to a treatment group that receives either pozelimab, cemdisiran, a combination of both, or a placebo. The study drugs are given as an injection under the skin, similar to a diabetes shot. You will have regular visits to the clinic where you will undergo various eye exams, including special scans and vision tests, and have blood samples taken. These tests help the researchers track the progression of your GA and monitor for any side effects or how the drugs are working in your body. The exact number and frequency of visits will be explained by the study team. Overall, you'll be part of the study for an extended period, which the research team will detail.
Potential risks and benefits
Locations (216)
- Barnet Dulaney Perkins Eye Center-OphthamalogyVerified postcodeChandler, United States· Recruiting
- Barnet Dulaney Perkins Eye CenterVerified postcodePhoenix, United States· Recruiting
- Associated Retina ConsultantsVerified postcodePhoenix, United States· Recruiting
- Retinal Research InstituteVerified postcodePhoenix, United States· Recruiting
- Retina Macula Institute of ArizonaVerified postcodeScottsdale, United States· Recruiting
- Retina Associates of TuscanVerified postcodeTucson, United States· Recruiting
- Retina Partners of Northwest Arkansas, PLLCVerified postcodeSpringdale, United States· Recruiting
- Retina Vitreous Associates Medical GroupVerified postcodeBeverly Hills, United States· Recruiting
- Retina Specialists of Beverly Hills- Department of OphthalmologyVerified postcodeBeverly Hills, United States· Recruiting
- The Retina PartnersVerified postcodeEncino, United States· Recruiting
- Eye Medical Center of FresnoVerified postcodeFresno, United States· Recruiting
- Retina Consultants of Orange CountyVerified postcodeFullerton, United States· Completed
Common questions
What is Geographic Atrophy (GA)?
GA is an advanced form of Age-related Macular Degeneration (AMD), leading to blind spots and loss of central vision due to the gradual breakdown of cells in the macula.
What are pozelimab and cemdisiran?
These are investigational drugs being tested in this study to see if they can help slow down the progression of Geographic Atrophy.
What is a placebo?
A placebo is an inactive treatment that looks exactly like the study drug but does not contain any active medicine. It's used for comparison to see if the real drug has a true effect.
How will I receive the study drugs?
The study drugs, or placebo, will be given through injections under the skin.
Can I leave the study at any time?
Yes, you are free to withdraw from the study at any point without it affecting your ongoing medical care.
How to find out more
Clinical Trials Administrator
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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