Avacincaptad Pegol for Macular Degeneration

Recruiting at 48 trial locations

Overseen By Astellas Pharma Global Development, Inc.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Astellas Pharma Global Development, Inc.

Must be taking: Avacincaptad pegol

Must not be taking: Intravitreal complement inhibitors

Disqualifiers: Ocular infection, Intraocular inflammation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 6

Duration: Up to 61 months

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the use of avacincaptad pegol, approved in the U.S., for managing geographic atrophy caused by age-related macular degeneration (AMD). Geographic atrophy is a severe eye condition where parts of the retina waste away, leading to vision loss. The study is observational, collecting data from participants' usual medical care and surveys about their eye health. It is suitable for individuals with geographic atrophy in one or both eyes who have already decided, with their doctor, to start treatment with avacincaptad pegol. Participants must be willing to complete surveys about their eye health throughout the study.

As a Phase 4 trial, this study highlights that avacincaptad pegol is already FDA-approved and proven effective, aiming to understand how the treatment benefits more patients.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you have received any intravitreal complement inhibitor other than avacincaptad pegol, you must complete a 90-day period without it before joining the study.

What is the safety track record for avacincaptad pegol?

Research has shown that Izervay, also known as avacincaptad pegol, maintains a consistent safety record in studies involving over 600 patients with geographic atrophy. These studies monitored patients for 12 and 24 months to identify any safety issues. The findings revealed that Izervay was well-tolerated, with no unexpected safety problems during that period. Additionally, a large real-world study involving over 10,000 patients treated with Izervay confirmed its long-term safety. This treatment is FDA-approved, indicating it has been reviewed and deemed safe for its intended use. While all medications can have side effects, evidence suggests that Izervay is generally safe for managing geographic atrophy in patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for geographic atrophy, which typically focuses on managing symptoms and slowing progression, Avacincaptad Pegol (Izervay™) is designed to directly target the complement system, a part of the immune system involved in the disease process. Researchers are excited about this treatment because it acts on the C5 protein, which plays a key role in inflammation and tissue damage in the retina. By inhibiting this protein, Izervay™ has the potential to slow or even halt the progression of geographic atrophy, offering hope for improved preservation of vision compared to existing treatments.

What is the effectiveness track record for avacincaptad pegol in treating geographic atrophy?

Studies have shown that Izervay (avacincaptad pegol), which participants in this trial may receive, can significantly slow the progression of geographic atrophy (GA), a serious form of age-related macular degeneration (AMD). In two clinical trials with 624 participants, Izervay reduced GA growth by 18% to 35% over one year. Another study found that it reduced lesion growth by 40.5% in patients using Izervay. This treatment helps protect vision in people at risk of permanent vision loss due to GA. Research supports Izervay's effectiveness, and it is approved in the U.S. for treating GA. ^{3 6 7 8 9}

Who Is on the Research Team?

Medical Director

Principal Investigator

Astellas Pharma Global Development, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am chosen to receive ACP eye injections before joining.

I have vision loss due to aging in one or both eyes.

I am willing to report on my health outcomes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive avacincaptad pegol as part of their routine clinical care, with treatment intervals determined by their doctor

Up to 61 months

Regular visits as per routine care

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys every 6 months for the first 2 years, then annually

Up to 61 months

Surveys every 6 months for 2 years, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Avacincaptad Pegol

How Is the Trial Designed?

Group I: Izervay Experimental Treatment 1 Intervention

Patients with geographic atrophy (GA) secondary to AMD who have made decision to begin treatment with Izervay

Who Is Running the Clinical Trial?

Astellas Pharma Global Development, Inc.

Lead Sponsor

Trials

204

Recruited

123,000+

Tadaaki Taniguchi

Astellas Pharma Global Development, Inc.

Chief Medical Officer

M.D., Ph.D.

Naoki Okamura

Astellas Pharma Global Development, Inc.

Chief Executive Officer

Not available

Citations

1. izervayecp.com izervayecp.com/efficacy

IZERVAY efficacy and post hoc data across two Phase 3 trials IZERVAY is the only treatment to demonstrate a statistically significant reduction in the rate of GA growth across two Phase 3 trials at 12 months7,8.

2. izervay.com izervay.com/how-izervay-works

IZERVAY slows GA progression: Clinical study results IZERVAY was proven to slow GA progression in 2 clinical trials evaluating 624 people with GA. IZERVAY slowed GA progression by 18%-35% compared to those who ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11060312/

Izervay (avacincaptad pegol): paving the way for vision ... Izervay represents a breakthrough in AMD treatment, offering the potential to preserve vision in those at risk of irreversible vision loss due to GA.

4. managedhealthcareexecutive.com managedhealthcareexecutive.com/view/izervay-continued-to-show-benefit-in-geographic-atrophy-in-open-label-study

Izervay Continued to Show Benefit in Geographic Atrophy ... Lesion growth was reduced by 40.5% in patients receiving Izervay in an open-label study. A real-world study confirms safety in more than ...

5. aao.org aao.org/eye-health/tips-prevention/syfovre-izervay-geographic-atrophy-amd-macular-deg

What to Know About Syfovre and Izervay for Geographic ... Two new drugs – Syfovre (pegcetacoplan) and Izervay (avacincaptad pegol) – were approved in 2023 for geographic atrophy, a potentially debilitating type of dry ...

6. izervayecp.com izervayecp.com/safety

IZERVAY safety profile in GATHER trials Explore IZERVAY's consistent safety profile in GATHER trials with over 600 GA patients. Learn about the safety data over 12 and 24 months.

7. izervay.com izervay.com/

Slow geographic atrophy (GA) with IZERVAY IZERVAY is FDA-approved for the treatment of GA. IZERVAY slows GA progression by directly targeting C5, a key source of retinal cell death and loss of ...

8. newsroom.astellas.com newsroom.astellas.com/2025-10-19-IZERVAY-TM-avacincaptad-pegol-intravitreal-solution-Showed-Increased-Benefit-in-Reducing-Geographic-Atrophy-Progression-Over-Time-and-Consistent-Long-Term-Safety

IZERVAY™ (avacincaptad pegol intravitreal solution) ... A separate real-world study highlighted treatment patterns and safety of IZERVAY in patients with GA (n=10,181 patients, 13,391 eyes) treated in ...

9. findgafirst.com findgafirst.com/assess-progression

Assess GA progression risks - Izervay Keep the risks of rapid geographic atrophy (GA) progression on your radar to identify which of your patients are most at risk.