Pegcetacoplan for Geographic Atrophy Over 30 Months: Data From OAKS, DERBY, and the GALE Long-Term Extension Study

Background and Objective This study will report safety and efficacy of pegcetacoplan for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Patients and Methods GALE is a phase 3, open-label, multicenter, 36-month extension of the OAKS and DERBY studies. Patients who receiv...

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Published in:Ophthalmic surgery, lasers & imaging Vol. 56; no. 7; pp. 398 - 406
Main Authors: Goldberg, Roger A., Boyer, David S., Holz, Frank G., MacCumber, Mathew W., Garg, Sunir J., Brown, David M., Lad, Eleonora M., Steinle, Nathan, Rishi, P. Singh, Pearce, Ian, Ach, Thomas, Ribeiro, Ramiro, Li, Chao, Jones, Daniel, Tsuboi, Min, Ferrone, Philip J., Baumal, Caroline R., Wykoff, Charles C.
Format: Journal Article
Language:English
Published: Thorofare, NJ SLACK Incorporated 01.07.2025
Slack, Inc
SLACK INCORPORATED
Subjects:
Age related diseases
Aged
Aged, 80 and over
Atrophy
Effectiveness
Enrollments
Exudation
Eye diseases
FDA approval
Female
Fluorescein Angiography - methods
Follow-Up Studies
Fundus Oculi
Geographic Atrophy - diagnosis
Geographic Atrophy - drug therapy
Geographic Atrophy - etiology
Hispanic Americans
Humans
Intravitreal Injections
Ischemia
Macular degeneration
Male
Medical research
Medicine, Experimental
Patients
Time Factors
Tomography, Optical Coherence - methods
Treatment Outcome
Vascular endothelial growth factor
Visual Acuity
United Kingdom
California
Georgia
United States
ISSN:2325-8160, 2325-8179, 2325-8179
Online Access:Get full text
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Summary:Background and Objective This study will report safety and efficacy of pegcetacoplan for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Patients and Methods GALE is a phase 3, open-label, multicenter, 36-month extension of the OAKS and DERBY studies. Patients who received pegcetacoplan monthly (PM) or every other month (PEOM) in OAKS or DERBY continued the same regimen in GALE (PM-PM and PEOM-PEOM); sham-observed patients initiated pegcetacoplan, maintaining the same interval. Results In the first 6 months of GALE, 3.0% of study eyes developed exudative AMD, 1.3% intraocular inflammation, 0.1% ischemic optic neuropathy, and none endophthalmitis. Pegcetacoplan reduced GA growth rate by 39% (PM-PM) and 32% (PEOM-PEOM), with increasing efficacy over time across GA subtypes. In eyes with nonsubfoveal GA, pegcetacoplan reduced GA growth rate by 45% (PM-PM) and 33% (PEOM-PEOM). Conclusion Pegcetacoplan reduced GA growth rate up to 45% with increasing efficacy over 30 months and demonstrated a favorable safety profile. [Ophthalmic Surg Lasers Imaging Retina 2025;56:398–406.]
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ISSN:2325-8160
2325-8179
2325-8179
DOI:10.3928/23258160-20250217-01