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

Roger A. Goldberg; David S. Boyer; Frank G. Holz; Mathew W. Maccumber; Sunir J. Garg; David M. Brown; Eleonora M. Lad; Nathan Steinle; Rishi P. Singh; Ian Pearce; Thomas Ach; Ramiro Ribeiro; Chao Li; Daniel Jones; Min Tsuboi; Philip J. Ferrone; Caroline R. Baumal; Charles C. Wykoff

doi:10.3928/23258160-20250217-01

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

Roger A. Goldberg, David S. Boyer, Frank G. Holz, Mathew W. Maccumber, Sunir J. Garg, David M. Brown, Eleonora M. Lad, Nathan Steinle, Rishi P. Singh, Ian Pearce, Thomas Ach, Ramiro Ribeiro, Chao Li, Daniel Jones, Min Tsuboi, Philip J. Ferrone, Caroline R. Baumal, Charles C. Wykoff

Research output: Contribution to journal › Article › peer-review

5 Scopus citations

Abstract

BACKGROUND AND OBJECTIVE: This study will report safety and efficacy of pegcetacoplan for geographic atrophy (GA) secondary to age-related mac-ular 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 pegceta-coplan 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% in-traocular inflammation, 0.1% ischemic optic neu-ropathy, 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.

Original language	English (US)
Pages (from-to)	398-406
Number of pages	9
Journal	Ophthalmic Surgery Lasers and Imaging Retina
Volume	56
Issue number	7
DOIs	https://doi.org/10.3928/23258160-20250217-01
State	Published - Jul 2025

ASJC Scopus subject areas

Surgery
Ophthalmology

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Goldberg, R. A., Boyer, D. S., Holz, F. G., Maccumber, M. W., Garg, S. J., Brown, D. M., Lad, E. M., Steinle, N., Singh, R. P., Pearce, I., Ach, T., Ribeiro, R., Li, C., Jones, D., Tsuboi, M., Ferrone, P. J., Baumal, C. R., & Wykoff, C. C. (2025). Pegcetacoplan for Geographic Atrophy Over 30 Months: Data From OAKS, DERBY, and the GALE Long-Term Extension Study. Ophthalmic Surgery Lasers and Imaging Retina, 56(7), 398-406. https://doi.org/10.3928/23258160-20250217-01

Goldberg, RA, Boyer, DS, Holz, FG, Maccumber, MW, Garg, SJ, Brown, DM, Lad, EM, Steinle, N, Singh, RP, Pearce, I, Ach, T, Ribeiro, R, Li, C, Jones, D, Tsuboi, M, Ferrone, PJ, Baumal, CR & Wykoff, CC 2025, 'Pegcetacoplan for Geographic Atrophy Over 30 Months: Data From OAKS, DERBY, and the GALE Long-Term Extension Study', Ophthalmic Surgery Lasers and Imaging Retina, vol. 56, no. 7, pp. 398-406. https://doi.org/10.3928/23258160-20250217-01

@article{e6f5efb83545451d8d3ec8b5603fe76c,

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

abstract = "BACKGROUND AND OBJECTIVE: This study will report safety and efficacy of pegcetacoplan for geographic atrophy (GA) secondary to age-related mac-ular 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 pegceta-coplan 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\% in-traocular inflammation, 0.1\% ischemic optic neu-ropathy, 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.",

author = "Goldberg, \{Roger A.\} and Boyer, \{David S.\} and Holz, \{Frank G.\} and Maccumber, \{Mathew W.\} and Garg, \{Sunir J.\} and Brown, \{David M.\} and Lad, \{Eleonora M.\} and Nathan Steinle and Singh, \{Rishi P.\} and Ian Pearce and Thomas Ach and Ramiro Ribeiro and Chao Li and Daniel Jones and Min Tsuboi and Ferrone, \{Philip J.\} and Baumal, \{Caroline R.\} and Wykoff, \{Charles C.\}",

note = "Publisher Copyright: {\textcopyright} 2025 Goldberg, Boyer, Holz, et al.;.",

year = "2025",

month = jul,

doi = "10.3928/23258160-20250217-01",

language = "English (US)",

volume = "56",

pages = "398--406",

journal = "Ophthalmic Surgery Lasers and Imaging Retina",

issn = "2325-8160",

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number = "7",

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TY - JOUR

T1 - Pegcetacoplan for Geographic Atrophy Over 30 Months

T2 - Data From OAKS, DERBY, and the GALE Long-Term Extension Study

AU - Goldberg, Roger A.

AU - Boyer, David S.

AU - Holz, Frank G.

AU - Maccumber, Mathew W.

AU - Garg, Sunir J.

AU - Brown, David M.

AU - Lad, Eleonora M.

AU - Steinle, Nathan

AU - Singh, Rishi P.

AU - Pearce, Ian

AU - Ach, Thomas

AU - Ribeiro, Ramiro

AU - Li, Chao

AU - Jones, Daniel

AU - Tsuboi, Min

AU - Ferrone, Philip J.

AU - Baumal, Caroline R.

AU - Wykoff, Charles C.

PY - 2025/7

Y1 - 2025/7

N2 - BACKGROUND AND OBJECTIVE: This study will report safety and efficacy of pegcetacoplan for geographic atrophy (GA) secondary to age-related mac-ular 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 pegceta-coplan 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% in-traocular inflammation, 0.1% ischemic optic neu-ropathy, 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.

AB - BACKGROUND AND OBJECTIVE: This study will report safety and efficacy of pegcetacoplan for geographic atrophy (GA) secondary to age-related mac-ular 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 pegceta-coplan 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% in-traocular inflammation, 0.1% ischemic optic neu-ropathy, 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.

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U2 - 10.3928/23258160-20250217-01

DO - 10.3928/23258160-20250217-01

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AN - SCOPUS:105010889761

SN - 2325-8160

VL - 56

SP - 398

EP - 406

JO - Ophthalmic Surgery Lasers and Imaging Retina

JF - Ophthalmic Surgery Lasers and Imaging Retina

IS - 7

ER -

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

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