An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD

Conditions

• Geographic Atrophy Secondary to Age-related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PEGCETACOPLAN (APL-2) — DRUG
  Complement (C3) Inhibitor

Study Details

This is a phase 3, open-label, multicenter, extension study to evaluate the long-term safety and efficacy of pegcetacoplan (APL-2) in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who participated in Study APL2-103 (NCT03777332) or completed the treatment at Month 24 of either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600).

Key Dates

Start date

Mar 4, 2021

Status verified

Jun 2025

Primary completion

Sep 5, 2025

Completion

Sep 5, 2025

Study Design

Enrollment

792 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pegcetacoplan, 15 mg/100 μL, monthly for up to 36 months
  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.
• Experimental: Pegcetacoplan, 15 mg/100 μL, every other month (EOM) for up to 36 months
  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.

Primary Outcome Measure

Incidence and severity of ocular and systemic adverse events [ Time Frame: Up to 36 Months ]

Locations (99)

Related coverage on Hipa.ai

• Pegcetacoplan Long-term GA Extension Study Completes Primary Phase
  Pegcetacoplan · Sep 5, 2025 · ClinicalTrials.gov

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