Supplementary Online Content Geloneck MM, Chuang AZ, Clark WL, et al. Refractive outcomes following bevacizumab monotherapy compared with conventional laser treatment: a randomized clinical trial. JAMA Ophthalmol. Published online August 7, 2014. doi:10.1001/jamaophthalmol.2014.2772. eappendix. BEAT-ROP group members etable 1. Baseline clinical and ROP risk factors (109 patients, 83.2% eligible patients) etable 2. Number of laser applications without and with recurrence (101 eyes, 83.5% eligible eyes) This supplementary material has been provided by the authors to give readers additional information about their work. 2014 American Medical Association. All rights reserved. 1
eappendix: BEAT-ROP Group Members The BEAT-ROP Cooperative Group members include: Principal Investigator: Helen A. Mintz-Hittner, MD (The University of Texas Health Science Center Houston Medical School); Investigators and Clinical Coordinators: Ricardo L. Liberman, MD, Khaled A. Tawansy, MD, Delphine M. Eichorst, MD, Robert A. King, MD; Christopher Bardorf, MD, and Melissa Rutt, BSN (Presbyterian-St. Luke s Hospital and Rocky Mountain Hospital for Children); 3) Children s Hospital of Illinois, OSF St. Francis Medical Center: James R. Hocker, MD, Steven J. Lichtenstein, MD, and Parashos A. Lagouros, MD (vitreo-retinal surgeon) (co-investigators); Julie A. Hodges, R.N.C., B.S.N. (clinical coordinator); 4) Palmetto Health Baptist Hospital, Columbia, SC: Sharon S. Ellis, M.D. (neonatologist) and W. Lloyd Clark, M.D. (vitreo-retinal surgeon) (co-investigators); Sharon Emory, R.N. (clinical coordinator); 5) Palmetto Health Richland Hospital, Columbia, SC: Victor N. Iskersky, M.D. (neonatologist) and W. Lloyd Clark, M.D. (vitreo-retinal surgeon) (coinvestigators); Sharon Emory, R.N. (clinical coordinator); 6) Driscoll Children s Hospital, Corpus Christi, TX: Patricia L. Ramsay, M.D., Ph.D. (neonatologist) and Helen A. Mintz-Hittner, M.D. (pediatric ophthalmologist) (co-investigators); Kathy S. Sanchez, R.N. (clinical coordinator); 7) Baylor University Medical Center, Dallas, TX: Craig T. Shoemaker, M.D. (neonatologist) and Rand W. B. Spencer, M.D. (vitreo-retinal surgeon) (coinvestigators); Rachel Ross, R.N., M.S.N. (clinical coordinator); 8) Del Sol Medical Center, El Paso, TX: Enrique N. Ponte, M.D. (neonatologist) and Helen A. Mintz-Hittner, M.D. (pediatric ophthalmologist) (co-investigators); Michael A. Lason, R.N., N.N.P.-B.C. (clinical coordinator); 9) Las Palmas Medical Center, El Paso, TX: Luis A. Ayo, M.D. (neonatologist) and Helen A. Mintz-Hittner, M.D. (pediatric ophthalmologist) (co-investigators); Sandra C. Dieguez (clinical coordinator); 10) R.E. Thomason Hospital, the University of Texas Health Science Center at El Paso-Medical School, El Paso, TX: Garrett S. Levin, M.D. (neonatologist) and Violeta Radenovich, M.D., M.P.H. (pediatric ophthalmologist) (co-investigators); Leticia Guerra, R.N. (clinical coordinator); 11) Cook Children s Medical Center, Fort Worth, TX: David M. Riley, M.D. (neonatologist), Michael G. Hunt, M.D. (pediatric ophthalmologist), E. Alan Packwood, M.D. (pediatric ophthalmologist), and Alan A. Norman, M.D. (pediatric ophthalmologist) (co-investigators); Melinda Meacham, R.N., M.S.N., C.C.R.C. (clinical coordinator); 12) Children s Memorial Hermann Hospital, the University of Texas Health Science Center at 2014 American Medical Association. All rights reserved. 2
Houston-Medical School, Houston, TX: Sophia Tsakiri, M.D. (neonatologist) and Helen A. Mintz-Hittner, M.D. (pediatric ophthalmologist) (coinvestigators); De Ann Pulido, R.N. (clinical coordinator); 13) Memorial Hermann Southwest Hospital, the University of Texas Health Science Center at Houston-Medical School, Houston, TX: Syed Hassan Haider, M.D. (neonatologist) and Helen A. Mintz-Hittner, M.D. (pediatric ophthalmologist) (co-investigators); Linda Wernecke, R.N. (clinical coordinator); 14) St. Joseph Medical Center, Houston, TX: Elizabeth O Donnell, M.D. (neonatologist) and Helen A. Mintz-Hittner, M.D. (pediatric ophthalmologist) (co-investigators); Maria Mares (clinical coordinator); 15) Clear Lake Regional Medical Center, Webster, TX : Harvinder S. Bedi, M.D. (neonatologist) and Helen A. Mintz- Hittner, M.D. (pediatric ophthalmologist) (co-investigators); Leah M. Best, R.N., N.N.P.-B.C., Ph.D. (clinical coordinator). Confirming Ophthalmologist: Ronan E. O Malley, M.D. (vitreo-retinal surgeon), Houston, TX. Compounding Pharmacist: Kenneth L. Hughes, R.Ph., Greenpark Compounding Pharmacy, Houston, TX. Research Assistants: Cary Warner, Clinical Research Unit at Memorial Hermann Hospital, Houston, TX; Research Assistant: Maria Mares, Houston, TX; Research Assistant: Linda M. Rhodes, Houston TX; Research Assistant: Susan M. Hittner, B.B.A., M.B.A., Houston, TX; Technical Assistant: Kimberly A. Mankiewicz, Ph.D. 2014 American Medical Association. All rights reserved. 3
etable 1. Baseline Clinical and ROP Risk Factors (109 Patients, 83.2% Eligible Variable Zone I (N=46 Patients; 83.6% Eligible Zone II Posterior (N=63 Patients; 82.9% Eligible IVB Laser IVB Laser (N=27 (N=19 (N=29 (N=34 Birth Weight (grams, mean ± SD) 625 ± 150 648 ± 89 699 ± 116 681 ± 150 Gestational Age (weeks, mean ± SD) 24.3 ± 1.3 23.9 ± 0.8 24.4 ± 1.2 24.5 ± 1.5 Gender (male, %) 16 (59%) 12 (63%) 20 (69%) 23 (68%) Race White (%) 5 (19%) 3 (16%) 3 (10%) 8 (24%) Black (%) 3 (11%) 5 (26%) 4 (14%) 8 (24%) Hispanic (%) 19 (70%) 10 (53%) 19 (66%) 16 (47%) 2014 American Medical Association. All rights reserved. 4
Others (%) 0 (0%) 1 (5%) 3 (10%) 2 (6%) Number in Pregnancy 1 (%) 19 (70%) 17 (89%) 22 (76%) 25 (74%) 2 (%) 6 (22%) 1 (5%) 7 (24%) 8 (24%) 3 (%) 2 (7%) 1 (5%) 0 (0%) 1 (3%) Apgar Score 1 Minute (mean ± SD) 4.2 ± 2.3 a 3.8 ± 2.6 5.3 ± 2.1 4.5 ± 2.2 a 5 minutes (mean ± SD) 6.6 ± 1.8 a 5.7 ± 2.8 7.1 ± 1.5 6.4 ± 2.0 a PMA at Randomization (weeks, mean ± SD) 34.3 ± 1.5 33.5 ± 1.6 35.3 ± 1.8 35.7 ± 2.0 PMA at Treatment (weeks, mean ± SD) 34.5 ± 1.5 33.6 ± 1.6 35.5 ± 1.8 35.8 ± 2.1 Duration of Hospitalization - Birth to Treatment (weeks, mean ± SD) 10.2 ± 1.3 9.6 ± 1.4 11.1 ± 2.2 11.3 ± 2.3 Sepsis, Culture Proven (%) 8 (30%) 7 (37%) 11 (38%) 16 (47%) 2014 American Medical Association. All rights reserved. 5
Necrotizing Enterocolitis Surgery (%) 7 (26%) 1 (5%) 6 (21%) 6 (18%) Intraventricular Hemorrhage (grade) I (%) 2 (7%) 2 (11%) 5 (17%) 1 (3%) II (%) 4 (15%) 3 (16%) 5 (17%) 3 (9%) III (%) 3 (11%) 2 (11%) 1 (3%) 4 (12%) IV (%) 2 (7%) 4 (21%) 5 (17%) 9 (26%) Periventricular Leukomalacia Mild (%) 2 (7%) 2 (11%) 1 ( 3%) 1 (3%) Moderate (%) 1 (4%) 0 (0%) 1 ( 3%) 3 (9%) Severe (%) 0 (0%) 3 (16%) 1 ( 3%) 0 (0%) a Apgar scores were not available for one infant receiving intravitreal bevacizumab (IVB) for zone I ROP and one infant receiving laser therapy for zone II posterior ROP, because the infants were born at home. PMA = post menstrual age. 2014 American Medical Association. All rights reserved. 6
etable 2. Number of Laser Applications Without and With Recurrence (101 Eyes, 83.5% Eligible Eyes) Number of Laser Applications (mean ± SD) [median; Range] Zone I (N=35 Eyes, 74.5% Eligible Eyes) 2526 ± 1162 [2150; 1475 to 5675] Without Recurrence With Recurrence (N=26 Eyes) (N=9 Eyes) 1990 ± 467 4072 ± 1198 [1987; 1475 to 3225 ] [3800; 1700 to 5675] Zone II Posterior (N=66 Eyes, 89.2% Eligible Eyes) 1954 ± 1288 [1688; 735 to 7175] P-value Without Recurrence With Recurrence (N=58 Eyes) (N=8 Eyes) <0.001* 1567 ± 476 4766 ± 1811 [1613; 735 to 2500] [4800; 2750 to 7175] P-value <0.001* * Significant difference between intravitreal bevacizumab (IVB) and laser treated eyes using mixed effect model. 2014 American Medical Association. All rights reserved. 7