Pegcetacoplan for Age-Related Macular Degeneration
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how pegcetacoplan works for individuals with geographic atrophy, a condition that damages the central part of the eye due to age-related macular degeneration (AMD). Researchers aim to understand the safety and tolerability of this treatment in real-world settings. Individuals diagnosed with geographic atrophy in one or both eyes and with better than 20/200 vision may be eligible to participate. This observational study records how patients respond to the treatment without altering their normal care routines. As a Phase 4 trial, it focuses on understanding how an already FDA-approved and effective treatment benefits more patients, providing valuable insights into its broader impact.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are participating in any other experimental treatments, you must stop those at least 6 weeks before starting this study.
What is the safety track record for Pegcetacoplan?
Research has shown that pegcetacoplan is generally safe. Over four years of data indicate that most patients tolerate it well. In the OAKS and DERBY studies, pegcetacoplan proved safe for different patient groups. It has also been effective and safe for treating conditions like paroxysmal nocturnal hemoglobinuria (PNH).
Although rare safety issues have been reported, they remain uncommon, and ongoing studies continue to monitor pegcetacoplan's safety. Overall, evidence suggests that patients usually tolerate pegcetacoplan well, with most experiencing few serious problems.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about pegcetacoplan (Syfovre) because it offers a novel approach to treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Unlike other treatments that primarily focus on slowing the progression of the disease, pegcetacoplan specifically targets and regulates the complement system, a part of the immune system that is believed to play a significant role in the development of GA. This unique mechanism of action could potentially provide a new way to manage GA, offering hope for slowing disease progression more effectively than existing options. Additionally, its targeted approach may result in fewer side effects compared to broader treatments, which is an encouraging prospect for patients and healthcare providers alike.
What is the effectiveness track record for Pegcetacoplan in treating geographic atrophy secondary to age-related macular degeneration?
Research has shown that pegcetacoplan effectively treats geographic atrophy (GA), a condition related to age-related macular degeneration. Studies indicate that pegcetacoplan slowed GA progression by up to 42% when administered monthly or every other month. This treatment can help protect vision by reducing retinal damage. These findings are promising, suggesting that pegcetacoplan can significantly help individuals with this eye condition maintain their vision longer. Participants in this trial will receive pegcetacoplan, while others will be in an observation group.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observation
Participants are observed for real-world safety, tolerability, and treatment patterns of Pegcetacoplan (Syfovre)
Follow-up
Participants are monitored for safety and effectiveness after observation
What Are the Treatments Tested in This Trial?
Interventions
- Pegcetacoplan
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Apellis Pharmaceuticals, Inc.
Lead Sponsor
Citations
Sobi to present New One-Year Data on pegcetacoplan's ...
New one-year data reinforces the robust and sustained efficacy of Aspaveli/Empaveli (pegcetacoplan) in patients with C3G and primary IC-MPGN. “ ...
2.
investors.apellis.com
investors.apellis.com/news-releases/news-release-details/new-one-year-data-reinforcing-robust-and-sustained-efficacyNew One-Year Data Reinforcing the Robust and Sustained ...
Complete proteinuria remission achieved in one-third of patients and sustained through one year: One-third of EMPAVELI-treated patients achieved ...
Efficacy and Safety Maintained up to 3 Years in Adults with ...
Pegcetacoplan markedly and rapidly (within 4 weeks) improved all efficacy measures, which stabilized close to (hemoglobin, FACIT-Fatigue) or ...
4.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/5669/527339/A-First-Report-from-the-COMPLETE-Study-on-the-RealA First Report from the COMPLETE Study on the Real-World ...
In Phase 3 trials, pegcetacoplan significantly improved hemoglobin (Hb) levels and other clinical parameters in C5i-experienced (PEGASUS) and - ...
Pegcetacoplan Treatment for Geographic Atrophy in Age ...
This study supports the effectiveness of pegcetacoplan for GA when administered monthly or every other month, with reductions in GA growth rate of up to 42% and ...
SYFOVRE® (pegcetacoplan injection) safety
SYFOVRE has 4 years of long-term safety data1,2. Through 2 years of OAKS and DERBY,. SYFOVRE has a demonstrated safety profile in a broad range of patients1.
Material Safety Data Sheet of Pegcetacoplan
Material Safety Data Sheet of Pegcetacoplan contains identification of substance and details of the supplier of the safety data sheet.
Safety and Efficacy of Pegcetacoplan in Adult Patients with ...
Pegcetacoplan, the first targeted complement component 3 (C3) PNH therapy, was safe and efficacious in treatment-naive and pre-treated patients with PNH in ...
9.
ashpublications.org
ashpublications.org/blood/article/145/4/397/525848/Safety-and-efficacy-of-pegcetacoplan-treatment-forSafety and efficacy of pegcetacoplan treatment for cold ...
This study demonstrated that pegcetacoplan is generally well tolerated and suggests it can be effective for patients with CAD and wAIHA.
10.
investors.apellis.com
investors.apellis.com/news-releases/news-release-details/apellis-provides-update-review-rare-safety-events-syfovrerApellis Provides Update on Review of Rare Safety Events ...
GALE (n=792) is a Phase 3, multicenter, open-label, extension study to evaluate the long-term efficacy and safety of SYFOVRE® (pegcetacoplan ...
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