TY - JOUR
T1 - Preoperative Bevacizumab for Tractional Retinal Detachment in Proliferative Diabetic Retinopathy
T2 - A Prospective Randomized Clinical Trial
AU - Pan-American Collaborative Retina Study (PACORES) Group
AU - Arevalo, J. Fernando
AU - Lasave, Andres F.
AU - Kozak, Igor
AU - Al Rashaed, Saba
AU - Al Kahtani, Eman
AU - Maia, Mauricio
AU - Farah, Michel E.
AU - Cutolo, Caroline
AU - Brito, Miguel
AU - Osorio, Claudia
AU - Navarro, Patricia
AU - Wu, Lihteh
AU - Berrocal, María H.
AU - Morales-Canton, Virgilio
AU - Serrano, Martin A.
AU - Graue-Wiechers, Federico
AU - Sabrosa, Nelson Alexandre
AU - Alezzandrini, Arturo A.
AU - Gallego-Pinazo, Roberto
AU - Arevalo, J. F.
AU - Liu, T. Y.A.
AU - Wu (PI), L.
AU - Lasave (PI), A. F.
AU - Farah (PI), M.
AU - Maia, M.
AU - Penha, F. M.
AU - Rodrigues, E. B.
AU - Morales-Canton (PI), V.
AU - Fromow-Guerra, J.
AU - Guerrero-Naranjo, J. L.
AU - Dalma-Weiszhausz, J.
AU - Velez-Montoya, R.
AU - Quiroz-Mercado, H.
AU - Rodriguez (PI), F. J.
AU - Gomez, F. E.
AU - Brieke, A. C.
AU - Goveto, A.
AU - Berrocal (PI), M. H.
AU - Cruz-Villegas, V.
AU - Graue-Wiechers (PI), F.
AU - Lozano-Rechy, D.
AU - Fulda-Graue, E.
AU - Roca (PI), J. A.
AU - Hernández, A.
AU - Saravia (PI), M. J.
AU - Schlaen, A.
AU - Rojas, J.
AU - Ingolotti, M.
AU - Avila (PI), M.
AU - Carla, L.
N1 - Funding Information:
All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. The authors indicate no financial support or financial conflict of interest. All authors attest that they meet the current ICMJE requirements to qualify as authors. Dr Arevalo obtained his PhD at Faculty of Health Sciences, Stellenbosch University, Stellenbosch, South Africa. This article is part of his PhD on “Intravitreal Bevacizumab as Anti–vascular Endothelial Growth Factor in the Management of Complications of Diabetic Retinopathy.”, Pan-American Collaborative Retina Study (PACORES), Members of the Pan-American Collaborative Retina Study (PACORES): J. F. Arevalo (principal investigator [PI]), T. Y. A. Liu, The Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland, USA; L. Wu (PI), Asociados de Macula, Vitreo y Retina de Costa Rica, San Jose, Costa Rica; A. F. Lasave (PI), Clinica Oftalmologica Centro Caracas and the Arevalo-Coutinho Foundation for Research in Ophthalmology, Caracas, Venezuela; M. Farah (PI), M. Maia, F. M. Penha, E. B. Rodrigues, Universidade Federal de São Paulo - Departamento de Oftalmologia - Instituto da Visão - Sao Paulo, Brazil; V. Morales-Canton (PI), J. Fromow-Guerra, J.L. Guerrero-Naranjo, J. Dalma-Weiszhausz, R Velez-Montoya, H. Quiroz-Mercado, Asociación para Evitar la Ceguera en México, Mexico City, Mexico; F. J. Rodriguez (PI), F. E. Gomez, A. C. Brieke, A. Goveto, Fundacion Oftalmologica Nacional, Universidad del Rosario, Bogota, Colombia; M.H. Berrocal (PI), V. Cruz-Villegas, University of Puerto Rico, San Juan, Puerto Rico; F. Graue-Wiechers (PI), D. Lozano-Rechy, E. Fulda-Graue, Fundacion Conde Valenciana, Mexico City, Mexico; J.A. Roca (PI), A. Hernández, Clínica Ricardo Palma, Lima, Peru; M. J. Saravia (PI), A. Schlaen, J. Rojas, M. Ingolotti, Hospital Universitario Austral, Buenos Aires, Argentina; M. Avila (PI), L. Carla, Universidade Federal de Goiás- Departamento de Oftalmologia - Goiânia, Brazil; J. Cardillo (PI), R. Jorge, Hospital de Olhos de Araraquara, and the Universidade de Sao Paulo, Sao Paulo, Brazil; C. Carpentier (PI), J. Verdaguer T. J.I. Verdaguer D. G. Sepúlveda, Fundacion Oftalmologica Los Andes, Santiago de Chile, Chile; A. Alezzandrini (PI), B. Garcia, M. Zas, OFTALMOS, Catedra de Oftalmologia, Universidad de Buenos Aires, Buenos Aires, Argentina; R. Gallego-Pinazo (PI), M. Diaz-Llopis, R. Dolz-Marco, Hospital La Fe, Universidad de Valencia, Spain; M. Figueroa (PI), I. Contreras, D. Ruiz-Casas, Hospital Universitario Ramón y Cajal, Departamento de Retina, and VISSUM Madrid, Madrid, Spain.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2019/11
Y1 - 2019/11
N2 - Purpose: To assess the effectiveness and safety of an intravitreal injection of 1.25 mg bevacizumab (IVB) as a preoperative adjunct to small-gauge pars plana vitrectomy (PPV) compared with PPV alone in eyes with tractional retinal detachment secondary to proliferative diabetic retinopathy. Methods: This prospective, double-masked, randomized, multicenter, active-controlled clinical trial enrolled 224 eyes of 224 patients between November 2013 and July 2015. All eyes underwent a baseline examination including best-corrected visual acuity, color photos, optical coherence tomography, and fluorescein angiography. Data were collected on intraoperative bleeding, total surgical time, early (<1 month) postoperative vitreous hemorrhage, and mean change in best-corrected visual acuity at 12 months. P < .05 was considered statistically significant. Results: A total of 214 patients (214 eyes) were randomized in a 1:1 ratio to PPV plus IVB ([study group] 102 eyes) or PPV plus sham ([control] 112 eyes). Iatrogenic retinal breaks were noted intraoperatively in 35 eyes (34.3%) in the study group, and 66 eyes (58.9%) in the control group (P = .001). Grade 2 intraoperative bleeding was noted in 32 (31.3%) eyes in the study group and 58 (51.7 %) eyes in the control group (P = .001). Endodiathermy was necessary in 28 (27.4 %) eyes in the study group, compared with 75 (66.9%) eyes in the control group (P = .0001). Mean surgical time was 71.3 ± 32.1 minutes in the study group and 83.6 ± 38.7 minutes in the control group (P = .061). Conclusion: Preoperative IVB seems to reduce intraoperative bleeding, improving surgical field visualization, and reducing intraoperative and postoperative complications.
AB - Purpose: To assess the effectiveness and safety of an intravitreal injection of 1.25 mg bevacizumab (IVB) as a preoperative adjunct to small-gauge pars plana vitrectomy (PPV) compared with PPV alone in eyes with tractional retinal detachment secondary to proliferative diabetic retinopathy. Methods: This prospective, double-masked, randomized, multicenter, active-controlled clinical trial enrolled 224 eyes of 224 patients between November 2013 and July 2015. All eyes underwent a baseline examination including best-corrected visual acuity, color photos, optical coherence tomography, and fluorescein angiography. Data were collected on intraoperative bleeding, total surgical time, early (<1 month) postoperative vitreous hemorrhage, and mean change in best-corrected visual acuity at 12 months. P < .05 was considered statistically significant. Results: A total of 214 patients (214 eyes) were randomized in a 1:1 ratio to PPV plus IVB ([study group] 102 eyes) or PPV plus sham ([control] 112 eyes). Iatrogenic retinal breaks were noted intraoperatively in 35 eyes (34.3%) in the study group, and 66 eyes (58.9%) in the control group (P = .001). Grade 2 intraoperative bleeding was noted in 32 (31.3%) eyes in the study group and 58 (51.7 %) eyes in the control group (P = .001). Endodiathermy was necessary in 28 (27.4 %) eyes in the study group, compared with 75 (66.9%) eyes in the control group (P = .0001). Mean surgical time was 71.3 ± 32.1 minutes in the study group and 83.6 ± 38.7 minutes in the control group (P = .061). Conclusion: Preoperative IVB seems to reduce intraoperative bleeding, improving surgical field visualization, and reducing intraoperative and postoperative complications.
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U2 - 10.1016/j.ajo.2019.05.007
DO - 10.1016/j.ajo.2019.05.007
M3 - Article
C2 - 31095954
AN - SCOPUS:85070541314
SN - 0002-9394
VL - 207
SP - 279
EP - 287
JO - American journal of ophthalmology
JF - American journal of ophthalmology
ER -