C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial

The complement pathway may play a key role in the pathogenesis of age-related macular degeneration (AMD). The safety and efficacy of avacincaptad pegol (Zimura, IVERIC bio Inc, New York, NY), a C5 inhibitor, were assessed in participants with geographic atrophy (GA) secondary to AMD (GATHER1 Study)....

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Vydáno v:Ophthalmology (Rochester, Minn.) Ročník 128; číslo 4; s. 576
Hlavní autoři: Jaffe, Glenn J, Westby, Keith, Csaky, Karl G, Monés, Jordi, Pearlman, Joel A, Patel, Sunil S, Joondeph, Brian C, Randolph, John, Masonson, Harvey, Rezaei, Kourous A
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States 01.04.2021
Témata:
Aged
Aged, 80 and over
Aptamers, Nucleotide - therapeutic use
Complement C5 - antagonists & inhibitors
Complement Inactivating Agents - therapeutic use
Double-Blind Method
Female
Fluorescein Angiography
Follow-Up Studies
Geographic Atrophy - diagnosis
Geographic Atrophy - drug therapy
Geographic Atrophy - physiopathology
Humans
Intravitreal Injections
Macular Degeneration - diagnosis
Macular Degeneration - drug therapy
Macular Degeneration - physiopathology
Male
Prospective Studies
Visual Acuity - physiology
GATHER1
GATHER2
geographic atrophy
Zimura
Complement
dry
avacincaptad pegol
age-related macular degeneration
C5 inhibitor
ISSN:1549-4713, 1549-4713
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Shrnutí:The complement pathway may play a key role in the pathogenesis of age-related macular degeneration (AMD). The safety and efficacy of avacincaptad pegol (Zimura, IVERIC bio Inc, New York, NY), a C5 inhibitor, were assessed in participants with geographic atrophy (GA) secondary to AMD (GATHER1 Study). International, prospective, randomized, double-masked, sham-controlled, pivotal phase 2/3 clinical trial. A total of 286 participants with GA secondary to AMD. The primary efficacy endpoint was the mean rate of change in GA over 12 months measured by fundus autofluorescence (FAF) at 3 timepoints: baseline, month 6, and month 12. The reduction in the mean rate of GA growth (square root transformation) over 12 months was 27.4% (P = 0.0072) for the avacincaptad pegol 2 mg cohort and 27.8% (P = 0.0051) for the avacincaptad pegol 4 mg cohort compared with their corresponding sham cohorts. The results for both dose groups were statistically significant. Avacincaptad pegol was generally well tolerated after monthly administration over 12 months. There were no avacincaptad pegol-related adverse events (AEs) or inflammation. Further, there were no ocular serious AEs (SAEs) and no cases of endophthalmitis. The most frequent ocular AEs were related to the injection procedure. Intravitreal administration of avacincaptad pegol 2 mg and 4 mg led to a significant reduction of GA growth in eyes with AMD over a 12-month period. Because C5 inhibition theoretically preserves C3 activity, it may offer additional safety advantages. A second confirmatory pivotal clinical trial is underway to confirm the efficacy and safety of avacincaptad pegol in slowing the GA growth (GATHER2 Study).
Bibliografie:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-1
content type line 23
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ISSN:1549-4713
1549-4713
DOI:10.1016/j.ophtha.2020.08.027