C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration
| Autor: | John Randolph, Harvey Masonson, Brian C. Joondeph, Keith Westby, Joel A. Pearlman, Sunil S. Patel, K.A. Rezaei, Karl G. Csaky, Glenn J. Jaffe, Jordi Monés |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
0303 health sciences
medicine.medical_specialty business.industry Intravitreal administration Macular degeneration medicine.disease Clinical trial Geographic atrophy 03 medical and health sciences Ophthalmology 0302 clinical medicine Endophthalmitis Internal medicine Age related Cohort 030221 ophthalmology & optometry Medicine business Adverse effect 030304 developmental biology |
| Zdroj: | Ophthalmology. 128:576-586 |
| ISSN: | 0161-6420 |
| DOI: | 10.1016/j.ophtha.2020.08.027 |
| Popis: | Purpose 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). Design International, prospective, randomized, double-masked, sham-controlled, pivotal phase 2/3 clinical trial. Participants A total of 286 participants with GA secondary to AMD. Main Outcome Measures 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. Results 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. Conclusions 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). |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|