Bevacizumab in High-Risk Corneal Transplantation : A Pilot Multicenter Prospective Randomized Control Trial
Copyright © 2022 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved..
PURPOSE: To determine the efficacy of local (subconjunctival and topical) bevacizumab (Avastin) treatment in patients undergoing vascularized high-risk corneal transplantation.
DESIGN: Pilot, prospective, randomized, double-blind, placebo-controlled clinical trial conducted at 5 clinical centers in the United States, India, and Brazil.
PARTICIPANTS: Patients aged > 18 years undergoing high-risk penetrating keratoplasty, defined as corneal neovascularization (NV) in 1 or more quadrants ≥2 mm from the limbus or extension of corneal NV to the graft-host junction in a previously failed graft.
METHODS: Patients were randomized to receive subconjunctival bevacizumab (2.5 mg/0.1 ml) or placebo at the time of surgery, followed by topical bevacizumab (10 mg/ml) or topical placebo, administered 4 times per day for 4 weeks.
MAIN OUTCOME MEASURE: The 52-week endothelial immune rejection rate.
RESULTS: Ninety-two patients were randomized to receive bevacizumab (n = 48) or control (n = 44). The 52-week endothelial rejection rate was 10% in the bevacizumab group and 19% in the control group (P = 0.20). Post hoc, extended follow-up at the lead study site showed an endothelial rejection rate of 3% in the bevacizumab group and 38% in the control group (P = 0.003). Treatment with bevacizumab was found to have a hazard ratio of 0.15 (95% confidence interval, 0.03-0.65, P = 0.01) in a post hoc Cox regression analysis.
CONCLUSIONS: In patients undergoing vascularized high-risk corneal transplantation, there was no statistically significant difference in the rate of endothelial rejection at 1 year in the bevacizumab treatment group compared with the control group. This study may have been underpowered to detect a difference between treatment groups, and taken together, our data suggest that, in the current trial design, bevacizumab has a positive but not (yet) significant effect on endothelial rejection.
| Errataetall: |
ErratumIn: Ophthalmology. 2022 Nov;129(11):1334. - PMID 36272763 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:129 |
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| Enthalten in: |
Ophthalmology - 129(2022), 8 vom: 09. Aug., Seite 865-879 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Dohlman, Thomas H [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 26.07.2022 Date Revised 24.12.2023 published: Print-Electronic ErratumIn: Ophthalmology. 2022 Nov;129(11):1334. - PMID 36272763 Citation Status MEDLINE |
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| doi: |
10.1016/j.ophtha.2022.03.024 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Bevacizumab in High-Risk Corneal Transplantation |b A Pilot Multicenter Prospective Randomized Control Trial |
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| 500 | |a Date Revised 24.12.2023 | ||
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| 500 | |a ErratumIn: Ophthalmology. 2022 Nov;129(11):1334. - PMID 36272763 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a PURPOSE: To determine the efficacy of local (subconjunctival and topical) bevacizumab (Avastin) treatment in patients undergoing vascularized high-risk corneal transplantation | ||
| 520 | |a DESIGN: Pilot, prospective, randomized, double-blind, placebo-controlled clinical trial conducted at 5 clinical centers in the United States, India, and Brazil | ||
| 520 | |a PARTICIPANTS: Patients aged > 18 years undergoing high-risk penetrating keratoplasty, defined as corneal neovascularization (NV) in 1 or more quadrants ≥2 mm from the limbus or extension of corneal NV to the graft-host junction in a previously failed graft | ||
| 520 | |a METHODS: Patients were randomized to receive subconjunctival bevacizumab (2.5 mg/0.1 ml) or placebo at the time of surgery, followed by topical bevacizumab (10 mg/ml) or topical placebo, administered 4 times per day for 4 weeks | ||
| 520 | |a MAIN OUTCOME MEASURE: The 52-week endothelial immune rejection rate | ||
| 520 | |a RESULTS: Ninety-two patients were randomized to receive bevacizumab (n = 48) or control (n = 44). The 52-week endothelial rejection rate was 10% in the bevacizumab group and 19% in the control group (P = 0.20). Post hoc, extended follow-up at the lead study site showed an endothelial rejection rate of 3% in the bevacizumab group and 38% in the control group (P = 0.003). Treatment with bevacizumab was found to have a hazard ratio of 0.15 (95% confidence interval, 0.03-0.65, P = 0.01) in a post hoc Cox regression analysis | ||
| 520 | |a CONCLUSIONS: In patients undergoing vascularized high-risk corneal transplantation, there was no statistically significant difference in the rate of endothelial rejection at 1 year in the bevacizumab treatment group compared with the control group. This study may have been underpowered to detect a difference between treatment groups, and taken together, our data suggest that, in the current trial design, bevacizumab has a positive but not (yet) significant effect on endothelial rejection | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, U.S. Gov't, Non-P.H.S. | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Angiogenesis | |
| 650 | 4 | |a Corneal transplantation | |
| 650 | 4 | |a Neovascularization | |
| 650 | 4 | |a Penetrating keratoplasty | |
| 650 | 4 | |a Vascular endothelial growth factor | |
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