Avacincaptad Pegol for Geographic Atrophy

No longer recruiting at 130 trial locations

Overseen By Yordak Salermo

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Astellas Pharma Global Development, Inc.

Disqualifiers: Did not complete ISEE2008, Pregnant, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: 17 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety of avacincaptad pegol, a new treatment for geographic atrophy (GA), a leading cause of vision loss. It targets individuals who participated in a previous study with this treatment. Eligible participants must have completed the earlier study, continue to experience GA, and commit to attending all trial visits for 18 months. As a Phase 3 trial, this study represents the final step before FDA approval, giving participants the opportunity to help potentially bring a new treatment to market.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that avacincaptad pegol is likely to be safe for humans?

Research has shown that avacincaptad pegol is generally well-tolerated. In a study on geographic atrophy (GA), patients experienced few side effects, mostly mild and related to the eyes, such as discomfort or redness. Another study comparing treatments found that avacincaptad pegol might cause fewer side effects than similar treatments.

Several human studies have tested the treatment, supporting its safety. Overall, avacincaptad pegol appears to be a safe option for treating geographic atrophy, based on current research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for geographic atrophy?

Unlike the standard of care for geographic atrophy, which currently lacks FDA-approved treatments, avacincaptad pegol is a new option that targets complement factor C5. This approach aims to slow down the progression of the disease by reducing inflammation and cell damage in the retina. Researchers are excited because this mechanism of action is novel and offers a potential breakthrough for patients who have limited options to manage this condition.

What evidence suggests that avacincaptad pegol might be an effective treatment for geographic atrophy?

Research has shown that avacincaptad pegol effectively treats geographic atrophy (GA), an eye condition. Studies indicate that this treatment slows the growth of damaged areas in the eye. In the GATHER1 trial, patients who received avacincaptad pegol experienced slower GA progression compared to those who did not receive the treatment. Additionally, real-world data suggest that avacincaptad pegol has similar positive effects on vision and eye health as other treatments. This evidence supports avacincaptad pegol as a promising option for managing GA. ^{1 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?

This trial is for patients aged 50 or older with a condition called Geographic Atrophy, who completed the GATHER2 study. They must be able to attend all visits over an 18-month period and not have dropped out of the previous study due to side effects.

Inclusion Criteria

Patient must have the ability to return for all trial visits for the duration of the 18-month trial

I am 50 or older with GA and finished the GATHER2 study up to Month 24.

Patient must provide new written informed consent for this OLE trial prior to participation

Exclusion Criteria

Patient did not complete Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham)

Patient did not enroll into this OLE trial within the 90 day enrollment period

I have never been removed from the ISEE2008 study due to side effects.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive avacincaptad pegol 2 mg monthly from Month 1 to Month 17

17 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

Open-label extension

Participants continue to receive avacincaptad pegol to assess long-term safety

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Avacincaptad Pegol

Trial Overview

The trial involves monthly injections of Avacincaptad pegol (2 mg) directly into the eye. It's designed for those who've already received this treatment in a prior study and aims to further evaluate its long-term effects.

How Is the Trial Designed?

Group I: avacincaptad pegol Experimental Treatment 1 Intervention

Participants will receive avacincaptad pegol 2 mg monthly from Month 1 to Month 17.

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

IVERIC bio, Inc.

Lead Sponsor

Trials

5

Recruited

1,100+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12408533/

Real-World Experience of Geographic Atrophy Treatment ...

In this study, avacincaptad pegol treatment led to a 2.03% rate of new nAMD conversion and a 3% rate of acute postinjection IOP elevation ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12069194/

Clinical Outcomes of Treatment of Geographic Atrophy

The management of geographic atrophy has advanced with therapies like pegcetacoplan and avacincaptad pegol showing clear benefits in slowing lesion growth.

3.

nature.com

nature.com/articles/s41433-023-02497-w

18-month findings from the GATHER1 trial | Eye

Over this 18-month study, ACP 2 mg and 4 mg showed continued reductions in the progression of GA growth compared to sham and continued to be generally well ...

4.

dovepress.com

dovepress.com/real-world-outcomes-with-complement-inhibitors-for-geographic-atrophy--peer-reviewed-fulltext-article-OPTH

Real-World Outcomes with Complement Inhibitors for ...

This real-world study reports that treatment with IVA and IVP have similar visual and anatomic outcomes at 12-months.

5.

ophthalmologyretina.org

ophthalmologyretina.org/article/S2468-6530(24)00238-0/fulltext

A Cost Effectiveness Analysis of Avacincaptad Pegol for ...

The purpose of this study was to evaluate the cost effectiveness of the treatment of geographic atrophy (GA) with intravitreal avacincaptad pegol (ACP) and to ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0002939425001990

Ocular Adverse Events Associated with Pegcetacoplan and ...

A.M. Khanani et al. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a ...

7.

aao.org

aao.org/education/editors-choice/avacincaptad-pegol-may-have-fewer-adverse-events-t

Avacincaptad Pegol May Have Fewer Adverse Events ...

A pharmacovigilance analysis identified a wide spectrum of adverse events (AEs) reported for both pegcetacoplan and avacincaptad pegol, the only FDA-approved ...

8.

ajo.com

ajo.com/article/S0002-9394(25)00199-0/fulltext

Ocular Adverse Events Associated with Pegcetacoplan and ...

Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial.

9.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2023/217225Orig1s000SumR.pdf

217225Orig1s000 SUMMARY REVIEW - accessdata.fda.gov

The data from two (OPH2003 and ISEE2008) studies contained in this application establishes the efficacy of avacincaptad pegol intravitreal ...