Pozelimab + Cemdisiran for Macular Degeneration
(SIENNA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two new treatments, pozelimab and cemdisiran, for individuals with Geographic Atrophy (GA), a condition that damages central vision due to Age-related Macular Degeneration (AMD). The goal is to determine if these treatments can slow GA progression compared to a placebo. Researchers aim to learn about potential side effects, the amount of drug entering the blood, and whether the body develops resistance to it. Individuals with GA due to AMD, clear vision in one eye, and no history of certain eye surgeries or treatments might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatments for GA.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are using systemic complement inhibitor therapy, chronic systemic corticosteroids, or systemic immunosuppressive therapy, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of pozelimab and cemdisiran is generally well tolerated. One study demonstrated that this combination effectively controlled the breakdown of red blood cells, with most patients managing the treatment without major problems.
For cemdisiran alone, studies have indicated it is safe and generally well tolerated. Various trials have tested it, and most participants did not experience severe side effects.
Both treatments are currently under study for safety and effectiveness in people with geographic atrophy due to age-related macular degeneration. These studies aim to understand treatment tolerance and identify any side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Pozelimab and Cemdisiran for macular degeneration because these treatments offer a fresh approach compared to existing options like anti-VEGF injections. Pozelimab is a monoclonal antibody that works by blocking complement component C5, which plays a role in inflammation and tissue damage, while Cemdisiran is an RNA interference therapy that reduces the production of the same complement component. This dual-action approach targets the disease from two different angles, potentially leading to better outcomes. Unlike traditional treatments that focus on inhibiting blood vessel growth, these new therapies aim to address the underlying inflammation and immune response, offering hope for improved vision preservation.
What evidence suggests that this trial's treatments could be effective for Geographic Atrophy?
In this trial, participants will receive either a combination of Pozelimab and Cemdisiran, Cemdisiran alone, or a placebo. Studies have shown that using Pozelimab and Cemdisiran together helps patients manage their disease by lowering certain blood markers, such as lactate dehydrogenase (LDH). This suggests it might slow the progression of conditions like Geographic Atrophy in Age-related Macular Degeneration (AMD). Cemdisiran alone has also shown promise. Other studies demonstrated that Cemdisiran improved outcomes for patients with various diseases, indicating its potential effectiveness. Both treatments are being tested in this trial to determine if they can help slow eye damage caused by AMD.14678
Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults with geographic atrophy (GA) due to age-related macular degeneration. Participants must have a certain level of vision in the study eye, an area of GA that fits specific size criteria, and be able to undergo required vaccinations. Those with GA affecting the center point of the fovea or who cannot complete imaging procedures are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either pozelimab in combination with cemdisiran, cemdisiran alone, or placebo to evaluate the progression rate of Geographic Atrophy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including side effects and antibody development
What Are the Treatments Tested in This Trial?
Interventions
- Cemdisiran
- Pozelimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School