What side effects are associated with this type of intervention?

Common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF (vascular endothelial growth factor) injections such as ranibizumab, aflibercept, and bevacizumab. These treatments can cause side effects like eye pain, increased intraocular pressure, vitreous floaters, and in rare cases, endophthalmitis. Pegcetacoplan, a Complement C3 Inhibitor, is being studied for its long-term safety and efficacy in treating geographic atrophy secondary to AMD. Similar treatments targeting the complement system may cause side effects such as injection site reactions, increased risk of infections, and potential inflammatory responses. Patients should discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for Age-Related Macular Degeneration (AMD), primarily focusing on anti-VEGF (vascular endothelial growth factor) therapies such as ranibizumab (Lucentis), aflibercept (Eylea), and brolucizumab (Beovu). These treatments work by inhibiting the growth of abnormal blood vessels in the retina. More recently, complement inhibitors like Pegcetacoplan, which targets the complement system involved in inflammation and immune response, are being studied for their efficacy in treating geographic atrophy secondary to AMD. While Pegcetacoplan is still under investigation, it represents a novel approach compared to traditional anti-VEGF therapies.

What other types of research exist?

Promising novel alternatives to Pegcetacoplan for AMD patients include: 1) Faricimab, a bispecific antibody targeting both VEGF-A and Ang-2, which has shown efficacy in reducing retinal fluid and improving vision. 2) Gene therapies like RGX-314, which aims to provide sustained anti-VEGF therapy through a single subretinal injection. 3) Zimura (avacincaptad pegol), another complement inhibitor targeting C5, which has demonstrated potential in reducing the progression of geographic atrophy in AMD patients.

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Complement Inhibitor

Pegcetacoplan for Age-Related Macular Degeneration (GALE Trial)

Phase 3

Waitlist Available

Research Sponsored by Apellis Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

If you have known allergies to fluorescein sodium, a solution that is injected into your body for eye testing; or to pegcetacoplan (the study drug) or any inactive substances in pegcetacoplan solution.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a medication called pegcetacoplan to see if it is safe and effective for people with a severe eye condition called geographic atrophy, which is related to age-related macular degeneration. The medication aims to protect the eye by blocking harmful immune responses. Pegcetacoplan has shown an acceptable safety profile in previous studies for geographic atrophy.

Who is the study for?

This trial is for people with a specific eye condition called geographic atrophy due to age-related macular degeneration, who were in previous related studies. They must have clear eyes for imaging and agree to birth control measures if applicable. Excluded are those with other significant eye diseases, current pregnancy or breastfeeding, known allergies to study substances, or conditions preventing study participation.

What is being tested?

The long-term safety and effectiveness of Pegcetacoplan (APL-2) are being tested in this phase 3 extension study on individuals with geographic atrophy secondary to AMD who participated in earlier related trials.

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions at the injection site within the eye, inflammation or infection around the eyes, and allergic responses to either Pegcetacoplan or components used during testing.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not allergic to fluorescein sodium or the study drug and its components.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from baseline in LL-BCVA score (study eye)

Change from baseline in NL-BCVA score (study eye)

Change from baseline in the total area of GA lesion(s) in the study eye (in mm2)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pegcetacoplan, 15 mg/100 μL, monthly for up to 36 monthsExperimental Treatment1 Intervention

Participants from Study APL2-103 (NCT03777332) or those who completed the treatment at Month 24 from either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600) and were administered monthly intravitreal (IVT) pegcetacoplan (15 mg/100 μL) or monthly sham will receive IVT pegcetacoplan (15 mg/100 μL) monthly for up to approximately 36 months.

Group II: Pegcetacoplan, 15 mg/100 μL, every other month (EOM) for up to 36 monthsExperimental Treatment1 Intervention

Participants from Study APL2-103 (NCT03777332) or those who completed the treatment at Month 24 from either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600) and were administered every other month (EOM) intravitreal (IVT) pegcetacoplan (15 mg/100 μL) or EOM sham will receive IVT pegcetacoplan (15 mg/100 μL) EOM for up to approximately 36 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PEGCETACOPLAN (APL-2)

2018

Completed Phase 1

~20

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Age-Related Macular Degeneration (AMD) include complement inhibitors like Pegcetacoplan, which target the complement system to reduce inflammation and slow retinal damage. This is important for AMD patients as excessive complement activation contributes to disease progression. Additionally, anti-VEGF therapies inhibit abnormal blood vessel growth and leakage, preserving vision. These mechanisms are crucial for effectively managing AMD and improving patient outcomes.