Rahul N Khurana1, Derek Kunimoto2, Young Hee Yoon3, Charles C Wykoff4, Andrew Chang5, Raj K Maturi6, Hansjürgen Agostini7, Eric Souied8, David R Chow9, Andrew J Lotery10, Masahito Ohji11, Francesco Bandello12, Rubens Belfort13, Xiao-Yan Li14, Jenny Jiao14, Grace Le14, Kimmie Kim14, Werner Schmidt14, Yehia Hashad14. 1. Northern California Retina Vitreous Associates, Mountain View, California. Electronic address: rnkhurana@gmail.com. 2. Retinal Consultants of Arizona, Phoenix, Arizona. 3. Asan Medical Center, University of Ulsan, Seoul, South Korea. 4. Retina Consultants of Houston, Houston, Texas. 5. Sydney Retina Clinic, Sydney, Australia; Save Sight Institute, University of Sydney, Sydney, Australia. 6. Midwest Eye Institute, Indianapolis, Indiana; Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana. 7. Eye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany. 8. Centre Hospitalier Creteil, Service Universitaire d'Ophthalmologie, Creteil, France. 9. St Michael's Hospital, University of Toronto, Toronto, Canada; Toronto Retina Institute, North York, Canada. 10. University of Southampton, Southampton, United Kingdom. 11. Department of Ophthalmology, Shiga University of Medical Science, Shiga, Japan. 12. University Vita-Salute Scientific Institute, Hospital San Raffaele, Milan, Italy. 13. Vision Institute, Federal University of São Paulo, São Paulo, Brazil. 14. Allergan, an AbbVie company, Irvine, California.
Abstract
PURPOSE: To report the 2-year efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) compared with monthly ranibizumab in patients with treatment-naïve neovascular age-related macular degeneration (nAMD). DESIGN: Two multicenter, randomized, phase 3 clinical trials with identical protocols (CEDAR and SEQUOIA). Analyses used pooled trial data. PARTICIPANTS: The trials enrolled 1888 patients (1 eye/patient) with active choroidal neovascularization secondary to age-related macular degeneration and best-corrected visual acuity (BCVA) of 24 to 73 Early Treatment Diabetic Retinopathy Study letters. METHODS: At enrollment, patients were assigned to study eye treatment with abicipar 2 mg every 8 weeks after initial doses at baseline and weeks 4 and 8 (abicipar Q8, n = 630), abicipar 2 mg every 12 weeks after initial doses at baseline and weeks 4 and 12 (abicipar Q12, n = 628), or ranibizumab 0.5 mg every 4 weeks (ranibizumab Q4, n = 630). MAIN OUTCOME MEASURES: Efficacy measures included stable vision (<15-letter loss in BCVA from baseline) and change from baseline in BCVA and central retinal thickness (CRT). Safety measures included adverse events (AEs). RESULTS: For patients who completed the study, efficacy of abicipar after initial doses was maintained through week 104. At week 104, the proportion of patients with stable vision was 93.0% (396/426), 89.8% (379/422), and 94.4% (470/498); mean change in BCVA from baseline was +7.8 letters, +6.1 letters, and +8.5 letters, and mean change in CRT from baseline was -147 μm, -146 μm, and -142 μm in the abicipar Q8 (14 injections), abicipar Q12 (10 injections), and ranibizumab Q4 (25 injections) groups, respectively. The overall incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3% from baseline through week 52 and 16.2%, 17.6%, and 1.3% from baseline through week 104 in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. CONCLUSIONS: Two-year results show efficacy of abicipar Q8 and Q12 in nAMD. First onset of IOI events with abicipar was much reduced in the second year and comparable with ranibizumab (0.8% and 2.3% vs. 1.0%). The extended duration of effect of abicipar allows for quarterly dosing and reduced treatment burden.
RCT Entities:
PURPOSE: To report the 2-year efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) compared with monthly ranibizumab in patients with treatment-naïve neovascular age-related macular degeneration (nAMD). DESIGN: Two multicenter, randomized, phase 3 clinical trials with identical protocols (CEDAR and SEQUOIA). Analyses used pooled trial data. PARTICIPANTS: The trials enrolled 1888 patients (1 eye/patient) with active choroidal neovascularization secondary to age-related macular degeneration and best-corrected visual acuity (BCVA) of 24 to 73 Early Treatment Diabetic Retinopathy Study letters. METHODS: At enrollment, patients were assigned to study eye treatment with abicipar 2 mg every 8 weeks after initial doses at baseline and weeks 4 and 8 (abicipar Q8, n = 630), abicipar 2 mg every 12 weeks after initial doses at baseline and weeks 4 and 12 (abicipar Q12, n = 628), or ranibizumab 0.5 mg every 4 weeks (ranibizumab Q4, n = 630). MAIN OUTCOME MEASURES: Efficacy measures included stable vision (<15-letter loss in BCVA from baseline) and change from baseline in BCVA and central retinal thickness (CRT). Safety measures included adverse events (AEs). RESULTS: For patients who completed the study, efficacy of abicipar after initial doses was maintained through week 104. At week 104, the proportion of patients with stable vision was 93.0% (396/426), 89.8% (379/422), and 94.4% (470/498); mean change in BCVA from baseline was +7.8 letters, +6.1 letters, and +8.5 letters, and mean change in CRT from baseline was -147 μm, -146 μm, and -142 μm in the abicipar Q8 (14 injections), abicipar Q12 (10 injections), and ranibizumab Q4 (25 injections) groups, respectively. The overall incidence of intraocularinflammation (IOI) AEs was 15.4%, 15.3%, and 0.3% from baseline through week 52 and 16.2%, 17.6%, and 1.3% from baseline through week 104 in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. CONCLUSIONS: Two-year results show efficacy of abicipar Q8 and Q12 in nAMD. First onset of IOI events with abicipar was much reduced in the second year and comparable with ranibizumab (0.8% and 2.3% vs. 1.0%). The extended duration of effect of abicipar allows for quarterly dosing and reduced treatment burden.
Authors: Helio V Neves da Silva; John Placide; Anne Duong; Yasmyne Ronquillo; Shannon McCabe; Majid Moshirfar Journal: Ther Adv Ophthalmol Date: 2022-04-26