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Efficacy of intravitreal aflibercept (IVT-AFL) administered using a treat-and-extend (T&E) regimen in patients with macular edema secondary to central retinal vein occlusion (CRVO): The CENTERA study results

Track:
Retina
What:
Paper Presentation | Présentation d'article
Part of:
When:
4:07 PM, Saturday 26 Jun 2021 (8 minutes)
How:
Discussion:
0

Authors: Varun Chaudhary, Michael Larsen, Nicole Eter, Clare Bailey, Sebastian Wolf, Thomas Schmelter, Helmut Allmeier, Jean-François Korobelnik.

Disclosure Block: V. Chaudhary: Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Alcon Laboratories, Bayer Healthcare, Novartis Pharma AG. Membership on advisory boards or speakers’ bureaus; Description of relationship(s); Served as a Scientific Advisor, Served as a Scientific Advisor, Served as a Scientific Advisor. Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Allergan Inc, Bayer Healthcare, Novartis Pharma AG. Funded grants or clinical trials; Description of relationship(s); Grant, Grant, Grant. M. Larsen: Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); AbbVie, Novartis, Bayer Alcon, Novo Nordisk, Allergan, Glaxo Smith Kline, Acucela. Funded grants or clinical trials; Description of relationship(s); Study Investigator and Consultant, and the Rigshospitalet has received compensation for clinical trials, Study Investigator and Consultant, and the Rigshospitalet has received compensation for clinical trials, Study Investigator and Consultant, and the Rigshospitalet has received compensation for clinical trials, Study Investigator and Consultant, and the Rigshospitalet has received compensation for clinical trials, Study Investigator and Consultant, and the Rigshospitalet has received compensation for clinical trials, Study Investigator and Consultant, and the Rigshospitalet has received compensation for clinical trials, Study Investigator and Consultant, and the Rigshospitalet has received compensation for clinical trials. N. Eter: All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Name of for-profit or not-for-profit organization(s); Roche, Bayer, Novartis, Allergan, Alimera. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Description of relationship(s); Consultant. C. Bailey: Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Bayer, Novartis, Alimera Sciences, Roche. Membership on advisory boards or speakers’ bureaus; Description of relationship(s); Attendance at advisory boards/lecture fees, Attendance at advisory boards/lecture fees, Attendance at advisory boards/lecture fees, Attendance at advisory boards/lecture fees. S. Wolf: Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Heidelberg Engineering. Funded grants or clinical trials; Description of relationship(s); Grant. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Name of for-profit or not-for-profit organization(s); Allergan, Bayer, Heidelberg Engineering, Novartis, Optos Inc, Zeiss, Roche. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Description of relationship(s); Consultant. T. Schmelter: All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Name of for-profit or not-for-profit organization(s); Bayer AG. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Description of relationship(s); Employee. H. Allmeier: All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Name of for-profit or not-for-profit organization(s); Bayer Consumer Care AG. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Description of relationship(s); Employee. J. Korobelnik: All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Name of for-profit or not-for-profit organization(s); Alcon, Allergan, Bayer, Kanghong, Krys, NanoRetina, Novartis, Novonordisk, Roche, Théa, Zeiss. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Description of relationship(s); Consultant.

Abstract Body:

Purpose: To evaluate the efficacy and safety of IVT-AFL T&E in patients with macular edema secondary to CRVO.
Study Design: CENTERA (NCT02800642; ethics approved) was a 76-week (W), open-label, single-arm, Phase 4 study performed at 42 sites in Canada, Europe, and Australia. Treatment-naïve patients aged ≥18 years with center-involved macular edema secondary to CRVO and best-corrected visual acuity (BCVA) of 73-24 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled.
Methods: Patients received 2mg IVT-AFL injections at baseline and every 4W until disease stability criteria were met, or until W20, whichever occurred first (initiation phase). The treatment interval was adjusted in 2W increments based on functional and anatomic outcomes (T&E phase). Monitoring occurred at each injection and mandatory visits. Co-primary endpoints: the proportion of patients who gained ≥15 letters from baseline to W76 and the proportion of patients with a mean treatment interval of ≥8W from the last initiation phase visit to W76. Other endpoints included the proportion of patients who achieved a last actual and intended treatment interval ≥8W (post-hoc analysis). The last intended treatment interval was defined as the next planned interval following the last visit up to W76. Safety was assessed throughout the study period.
Results: 160 patients were included in the full analysis set. Mean (standard deviation) age was 66.2 (13.4) years and 60.0% of patients were male. Mean number of injections was 5.3 (0.7): baseline to W24, 3.9 (1.3): W24-52, and 3.0 (1.3): W52-76. From baseline to W76, 65.6% (n=105; P<0.0001 [test against threshold of 40%]) of patients gained ≥15 letters. During the T&E phase, 45.0% (n=72; P=0.8822 [test against threshold of 50%]) of patients achieved a mean treatment interval of ≥8W. A last actual and last intended treatment interval of ≥8W was achieved by 63.1% (n=101) and 67.5% (n=108) of patients, respectively. Mean BCVA increased from 51.9 (16.8) letters at baseline to 72.3 (18.5) letters at W76 (mean change: +20.3 [19.5] letters), and mean central retinal thickness decreased from 759.9 (246.0) µm at baseline to 265.4 (57.9) µm at W76 (mean change: −496.1 [252.4] µm). Overall, 95.6% (n=153) of patients lost <15 letters from baseline to W76. The most common ocular treatment-emergent adverse event was reduced visual acuity (14.8%).
Conclusions: Clinically meaningful and significant improvements in functional and anatomic outcomes were achieved with IVT-AFL T&E in patients with macular edema secondary to CRVO. Most patients achieved a last actual and last intended treatment interval of ≥8W, indicating that treatment intervals may have been extended further had the study duration been longer. The safety profile of IVT-AFL was consistent with previous studies.

Speaker
2022 Planning Committee - Retina