← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

GALE Trial Summary

This trial is testing a long-term treatment for people with age-related macular degeneration.

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.Check my eligibility
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.See study design
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.

GALE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Eye
Secondary outcome measures
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)

GALE 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

Find a Location

Who is running the clinical trial?

Apellis Pharmaceuticals, Inc.Lead Sponsor
24 Previous Clinical Trials
2,825 Total Patients Enrolled

Media Library

Pegcetacoplan (APL-2) (Complement Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04770545 — Phase 3
Age-Related Macular Degeneration Research Study Groups: Pegcetacoplan, 15 mg/100 μL, monthly for up to 36 months, Pegcetacoplan, 15 mg/100 μL, every other month (EOM) for up to 36 months
Age-Related Macular Degeneration Clinical Trial 2023: Pegcetacoplan (APL-2) Highlights & Side Effects. Trial Name: NCT04770545 — Phase 3
Pegcetacoplan (APL-2) (Complement Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04770545 — Phase 3
Age-Related Macular Degeneration Patient Testimony for trial: Trial Name: NCT04770545 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available spots in this research study for new participants?

"This specific clinical trial is not looking for any new participants, as indicated by the clinicaltrials.gov website. This trial was first posted on March 4th, 2021 and was last updated on August 29th, 2022. Although this study is no longer active, there are 999 other trials that are still recruiting patients."

Answered by AI

How many locations are participating in this research project?

"One hundred different hospitals and clinics are currently participating in this trial. Please be aware that while the locations in Mountain View, Miami and Reno will have the least travel impact, there are many other options available closer to where you live."

Answered by AI

How many people have the opportunity to enroll in this clinical trial?

"This particular trial has wrapped up recruitment, with the last edit to the posting being on 8/29/2022. However, there are 988 other trials for patients with neoplasm metastasis and 11 for PEGCETACOPLAN (APL-2) that are still looking for participants."

Answered by AI

Have other clinical studies like this been conducted in the past?

"PEGCETACOPLAN (APL-2), a medication manufactured by Apellis Pharmaceuticals, Inc., is currently being tested in 11 live trials spread out over 26 countries and 164 cities. The first study was completed in 2018 and involved 21 patients. So far, 8 studies have been completed and it is currently in Phase 2 of the drug approval process."

Answered by AI

What are PEGCETACOPLAN (APL-2)'s dangers to consumers?

"PEGCETACOPLAN (APL-2) is estimated to be a safe medication, as it is currently in Phase 3 clinical trials. This means that, while there is some data supporting efficacy, there are multiple rounds of data supporting safety."

Answered by AI

Are there other investigations that have used PEGCETACOPLAN (APL-2)?

"PEGCETACOPLAN (APL-2) was first studied in 2018 at HealthONE Physician Care, Rocky Mountain Hospital for Children. So far, 8 clinical trials have been completed, with 11 more active studies currently underway; many of these in Mountain View, Florida."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Bascom Palmer Eye Institute
Graystone Eye

Why did patients apply to this trial?

I would like to supplement my income.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How much is the compensation?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD
2021. "An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04770545.
All > Age Related Macular Degeneration > Geographic Atrophy
~362 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top