Study to Evaluate a Pegcetacoplan (Syfovre®) Prefilled Syringe

Part of paid clinical trials in Bakersfield, California.

Sponsor
Apellis Pharmaceuticals, Inc.
Study ID
NCT07214740
Phase
PHASE3
Status
Completed

Conditions

  • Geographic Atrophy Secondary to Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a phase 3, open-label study to evaluate the safety of pegcetacoplan in a prefilled syringe (PFS)

Key Dates

Start date
Oct 24, 2025
Status verified
Dec 2025
Primary completion
Dec 12, 2025
Completion
Dec 12, 2025

Study Design

Enrollment
44 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pegcetacoplan, 15 mg/100 μL (single dose), intravitreal injection via prefilled syringe
    This is a 30-day, phase 3b, single-arm, open-label, multicenter study to evaluate the safety of IVT pegcetacoplan administered via PFS in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The study consists of a screening/baseline visit at day 1, a follow-up call at day 7, and an end of study visit at day 30.

Primary Outcome Measure

To evaluate safety and tolerability of intravitreal (IVT) pegcetacoplan administered via PFS by assessing incidence of ocular treatment-emergent adverse events (TEAEs) in the study eye [ Time Frame: Up to Day 30 ]

Locations (5)

FacilityCityStateZIPSite coordinators
California Retina ConsultantsBakersfieldCalifornia93309-
California Retina ConsultantsOxnardCalifornia93036-
Austin Retina AssociatesAustinTexas78705-
Retina Consultants of TexasKatyTexas77494-
Retina Consultants of TexasWoodlandTexas77384-

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