Jean-François Korobelnik1, Michael Larsen2, Nicole Eter3, Clare Bailey4, Sebastian Wolf5, Thomas Schmelter6, Helmut Allmeier7, Varun Chaudhary8. 1. Service d'Ophtalmologie, Centre Hospitalier Universitaire (CHU) Bordeaux, France; Bordeaux Population Health Research Center, Team Lifelong exposures health and aging (LEHA), Univ. Bordeaux, Institut National de la Santé et de la Recherche Médicale (INSERM), Unité mixte de recherche (UMR), Bordeaux, France. Electronic address: jean-francois.korobelnik@chu-bordeaux.fr. 2. Department of Ophthalmology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. 3. Department of Ophthalmology, University of Muenster Medical Center, Muenster, Germany. 4. Bristol Eye Hospital, Bristol, United Kingdom. 5. Department for Ophthalmology, Inselspital, University Hospital, University of Bern, Bern, Switzerland. 6. Department of Ophthalmology, Bayer AG, Berlin, Germany. 7. Bayer Consumer Care (HA), AG, Basel, Switzerland. 8. Hamilton Regional Eye Institute, St. Joseph's Healthcare Hamilton, Ontario, Canada, and Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Abstract
PURPOSE: To evaluate the efficacy and safety of intravitreal aflibercept (IVT-AFL) treat-and-extend dosing in patients with macular edema secondary to central retinal vein occlusion (CRVO). DESIGN: CENTERA (Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO; NCT02800642) was an open-label, Phase 4 clinical study. METHODS: Patients received 2 mg of IVT-AFL at baseline and every 4 weeks thereafter, until disease stability criteria were met (or until week 20), at which point treatment intervals were adjusted in 2-week increments based on functional and anatomic outcomes. RESULTS: From baseline to week 76, 105 patients (65.6%) (P <.0001 [test against threshold of 40%]) gained ≥15 letters; and, during the treat-and-extend phase, 72 patients (45.0%) (P = 0.8822 [test against threshold of 50%]) achieved a mean treatment interval of ≥8 weeks. A last and next planned treatment interval of ≥8 weeks was achieved by 101 patients (63.1%) and by 108 patients (67.5%), respectively. Mean ± SD best-corrected visual acuity increased from 51.9 ± 16.8 letters at baseline to 72.3 ± 18.5 letters at week 76 (mean change: +20.3 ± 19.5 letters), and central retinal thickness decreased from 759.9 ± 246.0 µm at baseline to 265.4 ± 57.9 µm at week 76 (mean change: -496.1 ± 252.4 µm). The safety profile of IVT-AFL was consistent with that of previous studies. CONCLUSIONS: Clinically meaningful improvements in functional and anatomic outcomes were achieved with IVT-AFL treat-and-extend dosing. Most patients achieved a last actual and last intended treatment interval of ≥8 weeks; therefore, treatment intervals may have been extended even further with a longer study duration.
PURPOSE: To evaluate the efficacy and safety of intravitreal aflibercept (IVT-AFL) treat-and-extend dosing in patients with macular edema secondary to central retinal vein occlusion (CRVO). DESIGN: CENTERA (Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO; NCT02800642) was an open-label, Phase 4 clinical study. METHODS:Patients received 2 mg of IVT-AFL at baseline and every 4 weeks thereafter, until disease stability criteria were met (or until week 20), at which point treatment intervals were adjusted in 2-week increments based on functional and anatomic outcomes. RESULTS: From baseline to week 76, 105 patients (65.6%) (P <.0001 [test against threshold of 40%]) gained ≥15 letters; and, during the treat-and-extend phase, 72 patients (45.0%) (P = 0.8822 [test against threshold of 50%]) achieved a mean treatment interval of ≥8 weeks. A last and next planned treatment interval of ≥8 weeks was achieved by 101 patients (63.1%) and by 108 patients (67.5%), respectively. Mean ± SD best-corrected visual acuity increased from 51.9 ± 16.8 letters at baseline to 72.3 ± 18.5 letters at week 76 (mean change: +20.3 ± 19.5 letters), and central retinal thickness decreased from 759.9 ± 246.0 µm at baseline to 265.4 ± 57.9 µm at week 76 (mean change: -496.1 ± 252.4 µm). The safety profile of IVT-AFL was consistent with that of previous studies. CONCLUSIONS: Clinically meaningful improvements in functional and anatomic outcomes were achieved with IVT-AFL treat-and-extend dosing. Most patients achieved a last actual and last intended treatment interval of ≥8 weeks; therefore, treatment intervals may have been extended even further with a longer study duration.
Authors: Lasse Jørgensen Cehofski; Anders Kruse; Alexander Nørgaard Alsing; Benn Falch Sejergaard; Jonas Ellegaard Nielsen; Anders Schlosser; Grith Lykke Sorensen; Jakob Grauslund; Bent Honoré; Henrik Vorum Journal: Molecules Date: 2022-05-24 Impact factor: 4.927