Final Outcomes from the Randomized RECOVERY Trial of Aflibercept for Retinal Nonperfusion in Proliferative Diabetic Retinopathy
Copyright © 2022 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved..
PURPOSE: Retinal nonperfusion (RNP) is an important biomarker for diabetic retinopathy (DR). Data suggest that consistent anti-VEGF pharmacotherapy can slow RNP development. The RECOVERY trial evaluated the impact of aflibercept (Eylea, Regeneron) on RNP among eyes with proliferative DR (PDR).
DESIGN: Prospective, randomized clinical trial with treatment crossover in the second year.
SUBJECTS: Eyes with PDR and RNP.
METHODS: At baseline, the subjects were randomized 1:1 to monthly (arm 1) or quarterly (arm 2) intravitreal 2 mg aflibercept. At the beginning of year 2, the treatment arms were crossed over so that the monthly-dosed subjects subsequently received quarterly dosing and the quarterly-dosed subjects subsequently received monthly dosing.
MAIN OUTCOME MEASURES: Change in total RNP area (mm2) through year 2. Secondary outcomes included Diabetic Retinopathy Severity Scale (DRSS) scores; best-corrected visual acuity; central subfield thickness; additional measures of RNP, including ischemic index (ISI); and adverse event incidence. Means and 95% confidence intervals were calculated.
RESULTS: Among all subjects, from baseline to year 2, the mean RNP increased from 235 mm2 to 402 mm2 (P < 0.0001), and the ISI increased from 25.8% to 50.4% (P < 0.0001). Increases in the mean RNP (P < 0.0001) and ISI (P < 0.0001) were also observed from year 1 to year 2. The mean total RNP increased from 264 mm2 at baseline to 386 mm2 (P < 0.0001) at year 2 in arm 1 and from 207 mm2 at baseline to 421 mm2 (P < 0.0001) at year 2 in arm 2 (P = 0.023, arm 1 vs. arm 2). Increases in the mean RNP for both treatment arms (P < 0.0001) were also specifically observed within year 2 (P = 0.32, arm 1 vs. arm 2). Compared with baseline, the DRSS scores at the end of year 2 improved in 82% (n = 27) of subjects and remained stable in 18% (n = 6), with no subjects experiencing worsening; at 2 years, the DRSS scores had improved by 2 or more steps in 65% (n = 11) and 81% (n = 13) of subjects in arms 1 and 2, respectively.
CONCLUSIONS: Through year 2 of the RECOVERY trial, both treatment arms experienced significant increases in RNP. Despite the expansion of the RNP area in nearly all subjects, 82% of subjects demonstrated an improvement in DRSS levels from baseline, with no subjects experiencing worsening in DRSS scores.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:6 |
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| Enthalten in: |
Ophthalmology. Retina - 6(2022), 7 vom: 15. Juli, Seite 557-566 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Wykoff, Charles C [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 12.07.2022 Date Revised 15.08.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.oret.2022.02.013 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM337889554 |
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| 100 | 1 | |a Wykoff, Charles C |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Final Outcomes from the Randomized RECOVERY Trial of Aflibercept for Retinal Nonperfusion in Proliferative Diabetic Retinopathy |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Completed 12.07.2022 | ||
| 500 | |a Date Revised 15.08.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a PURPOSE: Retinal nonperfusion (RNP) is an important biomarker for diabetic retinopathy (DR). Data suggest that consistent anti-VEGF pharmacotherapy can slow RNP development. The RECOVERY trial evaluated the impact of aflibercept (Eylea, Regeneron) on RNP among eyes with proliferative DR (PDR) | ||
| 520 | |a DESIGN: Prospective, randomized clinical trial with treatment crossover in the second year | ||
| 520 | |a SUBJECTS: Eyes with PDR and RNP | ||
| 520 | |a METHODS: At baseline, the subjects were randomized 1:1 to monthly (arm 1) or quarterly (arm 2) intravitreal 2 mg aflibercept. At the beginning of year 2, the treatment arms were crossed over so that the monthly-dosed subjects subsequently received quarterly dosing and the quarterly-dosed subjects subsequently received monthly dosing | ||
| 520 | |a MAIN OUTCOME MEASURES: Change in total RNP area (mm2) through year 2. Secondary outcomes included Diabetic Retinopathy Severity Scale (DRSS) scores; best-corrected visual acuity; central subfield thickness; additional measures of RNP, including ischemic index (ISI); and adverse event incidence. Means and 95% confidence intervals were calculated | ||
| 520 | |a RESULTS: Among all subjects, from baseline to year 2, the mean RNP increased from 235 mm2 to 402 mm2 (P < 0.0001), and the ISI increased from 25.8% to 50.4% (P < 0.0001). Increases in the mean RNP (P < 0.0001) and ISI (P < 0.0001) were also observed from year 1 to year 2. The mean total RNP increased from 264 mm2 at baseline to 386 mm2 (P < 0.0001) at year 2 in arm 1 and from 207 mm2 at baseline to 421 mm2 (P < 0.0001) at year 2 in arm 2 (P = 0.023, arm 1 vs. arm 2). Increases in the mean RNP for both treatment arms (P < 0.0001) were also specifically observed within year 2 (P = 0.32, arm 1 vs. arm 2). Compared with baseline, the DRSS scores at the end of year 2 improved in 82% (n = 27) of subjects and remained stable in 18% (n = 6), with no subjects experiencing worsening; at 2 years, the DRSS scores had improved by 2 or more steps in 65% (n = 11) and 81% (n = 13) of subjects in arms 1 and 2, respectively | ||
| 520 | |a CONCLUSIONS: Through year 2 of the RECOVERY trial, both treatment arms experienced significant increases in RNP. Despite the expansion of the RNP area in nearly all subjects, 82% of subjects demonstrated an improvement in DRSS levels from baseline, with no subjects experiencing worsening in DRSS scores | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Anti-vascular endothelial growth factor | |
| 650 | 4 | |a Diabetic Retinopathy Severity Scale | |
| 650 | 4 | |a Ischemic index | |
| 650 | 4 | |a Proliferative diabetic retinopathy | |
| 650 | 4 | |a Retinal nonperfusion | |
| 650 | 7 | |a Recombinant Fusion Proteins |2 NLM | |
| 650 | 7 | |a aflibercept |2 NLM | |
| 650 | 7 | |a 15C2VL427D |2 NLM | |
| 650 | 7 | |a Receptors, Vascular Endothelial Growth Factor |2 NLM | |
| 650 | 7 | |a EC 2.7.10.1 |2 NLM | |
| 700 | 1 | |a Nittala, Muneeswar G |e verfasserin |4 aut | |
| 700 | 1 | |a Villanueva Boone, Cecilia |e verfasserin |4 aut | |
| 700 | 1 | |a Yu, Hannah J |e verfasserin |4 aut | |
| 700 | 1 | |a Fan, Wenying |e verfasserin |4 aut | |
| 700 | 1 | |a Velaga, Swetha Bindu |e verfasserin |4 aut | |
| 700 | 1 | |a Ehlers, Justis P |e verfasserin |4 aut | |
| 700 | 1 | |a Ip, Michael S |e verfasserin |4 aut | |
| 700 | 1 | |a Sadda, SriniVas R |e verfasserin |4 aut | |
| 700 | 0 | |a RECOVERY Study Group |e verfasserin |4 aut | |
| 700 | 1 | |a Wykoff, Charles C |e investigator |4 oth | |
| 700 | 1 | |a Nittala, Muneeswar G |e investigator |4 oth | |
| 700 | 1 | |a Villanueva Boone, Cecilia |e investigator |4 oth | |
| 700 | 1 | |a Yu, Hannah J |e investigator |4 oth | |
| 700 | 1 | |a Zhou, Brenda |e investigator |4 oth | |
| 700 | 1 | |a Fan, Wenying |e investigator |4 oth | |
| 700 | 1 | |a Velaga, Swetha Bindu |e investigator |4 oth | |
| 700 | 1 | |a Rusakevich, Alexander M |e investigator |4 oth | |
| 700 | 1 | |a Lampen, Shaun I R |e investigator |4 oth | |
| 700 | 1 | |a Ip, Michael S |e investigator |4 oth | |
| 700 | 1 | |a Sadda, SriniVas R |e investigator |4 oth | |
| 700 | 1 | |a Ehlers, Justis P |e investigator |4 oth | |
| 700 | 1 | |a Srivastava, Sunil K |e investigator |4 oth | |
| 700 | 1 | |a Reese, Jamie L |e investigator |4 oth | |
| 700 | 1 | |a Babiuch, Amy |e investigator |4 oth | |
| 700 | 1 | |a Talcott, Katherine |e investigator |4 oth | |
| 700 | 1 | |a Figueiredo, Natalia |e investigator |4 oth | |
| 700 | 1 | |a Yordi, Sari |e investigator |4 oth | |
| 700 | 1 | |a Hach, Jenna |e investigator |4 oth | |
| 700 | 1 | |a Ou, William C |e investigator |4 oth | |
| 700 | 1 | |a Fish, Richard H |e investigator |4 oth | |
| 700 | 1 | |a Benz, Matthew S |e investigator |4 oth | |
| 700 | 1 | |a Chen, Eric |e investigator |4 oth | |
| 700 | 1 | |a Kim, Rosa Y |e investigator |4 oth | |
| 700 | 1 | |a Major, James C |c Jr |e investigator |4 oth | |
| 700 | 1 | |a O'Malley, Ronan E |e investigator |4 oth | |
| 700 | 1 | |a Brown, David M |e investigator |4 oth | |
| 700 | 1 | |a Shah, Ankoor R |e investigator |4 oth | |
| 700 | 1 | |a Schefler, Amy C |e investigator |4 oth | |
| 700 | 1 | |a Wong, Tien P |e investigator |4 oth | |
| 700 | 1 | |a Henry, Christopher R |e investigator |4 oth | |
| 700 | 1 | |a Patel, Sagar B |e investigator |4 oth | |
| 700 | 1 | |a Nguyen, Vy T |e investigator |4 oth | |
| 700 | 1 | |a Larkin, Kelly L |e investigator |4 oth | |
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