This clinical trial is focused on studying a condition called Geographic Atrophy, which is a form of vision loss associated with Age-Related Macular Degeneration (AMD). The study will explore the effects of two treatments: Pozelimab and Cemdisiran. Pozelimab, also known by its code name REGN3918, and Cemdisiran, also known as ALN-CC5, are both administered as solutions for injection. The trial will also include a placebo group for comparison.
The purpose of the study is to evaluate how these treatments affect the growth of lesions, or damaged areas, in the eye over a period of 52 weeks. Participants will receive either Pozelimab in combination with Cemdisiran, Cemdisiran alone, or a placebo. The study will involve regular visits to the clinic for injections and monitoring of eye health. Participants will undergo various tests to assess changes in their vision and the size of the lesions in their eyes.
This trial aims to provide valuable information on the safety and effectiveness of these treatments for individuals with Geographic Atrophy due to Age-Related Macular Degeneration. The study will help determine if these medications can slow down the progression of the disease and improve or maintain vision in affected individuals.
1initial assessment
The study begins with an initial assessment to confirm eligibility. This includes checking the condition of the eye affected by geographic atrophy, ensuring it meets specific criteria such as the size of the affected area and visual acuity.
The assessment also involves ensuring the eye is suitable for quality imaging and that the participant is willing to comply with study procedures, including necessary vaccinations.
2treatment administration
Participants receive subcutaneous injections of either cemdisiran, pozelimab, or a combination of both. These are solutions for injection administered under the skin.
The placebo for cemdisiran is a saline solution, while the placebo for pozelimab is an aqueous buffered solution. These are also administered subcutaneously.
3monitoring and follow-up
Participants are monitored regularly to assess the growth rate of the geographic atrophy lesion area using fundus autofluorescence imaging.
Visual acuity and other visual functions are evaluated at consecutive study visits to track any changes.
4evaluation of treatment effects
The study evaluates the concentrations of pozelimab and cemdisiran in the blood, as well as changes in the concentration of Complement component 5 (C5).
The presence of antibodies against the medications is also monitored to assess any immune response.
5safety assessment
The occurrence and severity of any adverse events are recorded throughout the study to ensure participant safety.
The study aims to identify any treatment-emergent adverse events and their impact on participants.
Who Can Join the Study?
The patient must have a study eye with a diagnosis of Geographic Atrophy (GA) of the macula, which is a part of the eye, due to Age-Related Macular Degeneration (AMD). The GA should not involve the center point of the fovea, which is the small pit in the retina responsible for sharp vision.
The total area of GA in the study eye should measure between 2.5 mm² and 17.5 mm².
The patient should have a Best Corrected Visual Acuity (BCVA) of 35 letters or better using ETDRS charts, which is a method to measure vision, equivalent to 20/200 on the Snellen chart, in the study eye.
The patient must have clear enough eye media, which means the parts of the eye that light passes through, and adequate pupillary dilation and fixation to allow for quality imaging of the back of the eye.
The patient must be willing and able to attend clinic visits and follow study-related procedures, including completing a full series of meningococcal and pneumococcal vaccinations, which are vaccines to prevent certain infections.
The study is open to both male and female participants.
The study does not include vulnerable populations, which means groups that might need special protection.
Who Cannot Join the Study?
Patients with any other eye disease that could affect the study results.
Patients who have had eye surgery within the last 3 months.
Patients who are currently participating in another clinical trial.
Patients with a history of severe allergic reactions to medications.
Patients with uncontrolled high blood pressure.
Patients with a history of heart attack or stroke in the last 6 months.
Patients with severe kidney or liver disease.
Patients who are pregnant or breastfeeding.
Patients with any condition that the study doctors believe would make it unsafe to participate.
Pozelimab is a medication being studied for its potential to help with geographic atrophy, a condition related to age-related macular degeneration. It is administered through an injection under the skin. The goal of using this medication is to see if it can slow down the growth of lesions in the eye by inhibiting a part of the immune system known as Complement Component 5 (C5).
Cemdisiran is another medication involved in the study, which is also being tested for its effects on geographic atrophy. Like Pozelimab, it is used to target the immune system, specifically aiming to reduce the activity of Complement Component 5 (C5). This medication is being tested both on its own and in combination with Pozelimab to determine its effectiveness in slowing down the progression of the disease.
Geographic Atrophy Secondary to Age-Related Macular Degeneration – This disease is a progressive eye condition that affects the macula, the central part of the retina responsible for sharp vision. It is characterized by the gradual degeneration of retinal cells, leading to the formation of atrophic areas where the cells have died. Over time, these areas expand, causing a loss of central vision, which is crucial for activities like reading and recognizing faces. The progression of the disease is typically slow, but it can vary among individuals. It is a common form of advanced age-related macular degeneration, primarily affecting older adults. The condition does not usually cause complete blindness, as peripheral vision is often preserved.
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