Efficacy and Safety of Abicipar in Neovascular Age-Related Macular Degeneration
| Autor: | Derek Y Kunimoto, Andrew J. Lotery, Yehia Hashad, Rahul N. Khurana, Charles C. Wykoff, Young Hee Yoon, Francesco Bandello, Werner Schmidt, Cedar, Eric H Souied, Grace Le, Jenny Jiao, David R. Chow, Andrew Chang, Xiao-yan Li, Sequoia Study Groups, Hansjürgen Agostini, Masahito Ohji, Rubens Belfort, Raj K. Maturi |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Visual acuity genetic structures law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Ophthalmology medicine Clinical endpoint 030304 developmental biology 0303 health sciences business.industry Diabetic retinopathy Macular degeneration medicine.disease eye diseases Clinical trial Choroidal neovascularization 030221 ophthalmology & optometry medicine.symptom Ranibizumab business medicine.drug |
| Zdroj: | Ophthalmology. 127:1331-1344 |
| ISSN: | 0161-6420 |
| DOI: | 10.1016/j.ophtha.2020.03.035 |
| Popis: | Purpose To compare the efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) versus ranibizumab every 4 weeks in treatment-naive patients with neovascular age-related macular degeneration (AMD). Design Two randomized, multicenter, double-masked, parallel-group, active-controlled, phase 3 clinical trials (CEDAR, SEQUOIA) with identical protocols were conducted. Data from both trials were pooled for analysis. Participants Patients with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24–73 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled. Methods Patients (n = 1888) were randomized in a 1:1:1 ratio to study eye treatment with abicipar 2 mg every 8 weeks after 3 initial doses at baseline and weeks 4 and 8 (Q8), abicipar 2 mg every 12 weeks after 3 initial doses at baseline and weeks 4 and 12 (Q12), or ranibizumab 0.5 mg every 4 weeks (Q4). Main Outcome Measures The primary efficacy end point was proportion of patients with stable vision (defined as Results The proportion of patients with stable vision at week 52 was 93.2%, 91.3%, and 95.8% in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively, with both abicipar Q8 and Q12 noninferior to ranibizumab Q4. Week 52 mean change from baseline in BCVA was 7.5, 6.4, and 8.4 letters and in CRT was −144, −145, and −144 μm in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. Incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3%, respectively. The IOI AEs were typically mild or moderate in severity and treated with topical corticosteroids; 62 of 192 patients (32.3%) received oral and/or injectable corticosteroids. Conclusions Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52. Intraocular inflammation was more frequent with abicipar. Quarterly and Q8 abicipar reduce nAMD disease and treatment burden compared with monthly treatment. |
| Databáze: | OpenAIRE |
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