Pegcetacoplan for Age-Related Macular Degeneration
(GALE Trial)

Recruiting in Palo Alto (17 mi)

+174 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Apellis Pharmaceuticals, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

For subjects who participated in either the 303 or 304 studies, the condition listed below must also be met for participating in this study.

I am a woman.

Women who can have children must have a negative result of a blood pregnancy test on the first day of the study visit and agree to use ways to avoid pregnancy during the study and 90 days after the last dose of the study medication.

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Exclusion Criteria

My eye does not have any disqualifying conditions for the study.

If, according to your doctor, any current disease that could directly interfere in your participation in the study or that could make it difficult for you to come to the scheduled visits during the next three years over the next 36 months.

If you currently are pregnant, breastfeed or have a positive pregnancy test.

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Participant Groups

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.

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.