Intravitreal bevacizumab (IVB) versus IVB in combination with pars plana vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy: a randomized clinical trial

International Journal of Retina and Vitreous - 2021
Danilo Moyses Jorge1, José Edísio da Silva Tavares Neto1, Omero Benedicto Poli-Neto2, Ingrid U. Scott3, Rodrigo Jorge1
1Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, 14048-900, Brazil
2Department of Gynecology and Obstetrics, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil
3Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA

Tóm tắt

Abstract Background The main purpose of this study is to compare the vitreous hemorrhage (VH) score reduction and visual acuity outcomes in patients with VH secondary to proliferative diabetic retinopathy (PDR) treated with intravitreal injections of bevacizumab (IVB) versus IVB and pars plana vitrectomy (IVB and PPV). Methods Patients with VH secondary to PDR were randomized into 2 groups: in Group A, patients were treated with a total of 3 IVB (1.5 mg/0.06 ml) at 8-week intervals; and in Group B, patients received a single IVB (1.5 mg/0.06 ml) and, 7 days later, underwent PPV. Patients received an ophthalmic evaluation that included best-corrected visual acuity (BCVA), indirect ophthalmoscopy, and mode B echography at weeks 8, 16 and 24. VH was classified according to the Diabetic Retinopathy Vitrectomy Study classification as grade 1, 2 or 3. Change in VH score was the primary outcome measure and change in BCVA was the secondary outcome. Results Seventy-three eyes of 66 patients were randomized and 70 eyes completed the 24-week follow-up visit. Mean VH score reduction (± SEM) of 0.4571 ± 0.0283 (p = 0.0014), 1.3429 ± 0.0393 (p < 0.0001) and 1.8286 ± 0.0438 (p < 0.001) was observed in Group A at 8, 16 and 24 weeks after treatment, respectively (Table 2; Fig. 2). In Group B, the reduction of VH score (± SEM) was 2.2571 ± 0.0720 (p = 0.0014), 2.2857 ± 0.0606 (p < 0.0001) and 2.2286 ± 0.0726 (p < 0.001) at 8, 16 and 24 weeks after treatment, respectively. Group comparison revealed a significantly greater reduction in mean VH score in Group B at 8 and 16 weeks after treatment (p < 0.0001). However, at 24 weeks this difference was no longer statistically significant (p = 0.1854). In Group A, mean (± SEM) BCVA showed an improvement of 0.00285 ± 0.0004 (p = 0.971), 0.5371 ± 0.0072 (p < 0.0001), 0.8143 ± 0.0001 (p < 0.0001) and 0.8543 ± 0.0008 (p < 0.0001) compared to baseline at 1, 8, 16 and 24 weeks after treatment, respectively. In Group B, mean (± SEM) BCVA showed an improvement of 0.3657 ± 0.0507 (p = 0.0002), 0.8857 ± 0.0385 (p < 0.0001), 0.9457 ± 0.0499 (p < 0.0001) and 0.9629 ± 0477 (p < 0.0001) compared to baseline at 1, 8, 16 and 24 weeks after treatment, respectively. No significant difference in BCVA improvement was observed between groups at 24 weeks after treatment. Conclusion PPV with preoperative IVB is associated with more rapid clearance of VH and improvement in BCVA than IVB injections alone. However, after 24 weeks of follow-up, the reduction in VH score and BCVA were similar between both treatment strategies. Trial Registration The project is registered in Plataforma Brasil with CAAE number 927354.7.0000.5440 and was approved by the Ethics Committee of the Clinics Hospital of Ribeirao Preto Medicine School of São Paulo University—Ribeirão Preto, São Paulo, Brazil (appreciation number 3.053.397 gave the approval).

Từ khóa


Tài liệu tham khảo

Dias AFG, et al. Perfil epidemiológico e nível de conhecimento de pacientes diabéticos sobre diabetes e retinopatia diabética. Arq Bras Oftalmol. 2010;73(5):414–8.

Chew EY. Major clinical trials of vitreoretinal diseases. In: Regillo CD, Brown GC, Flyn HW, editors. Vitreoretinal disease, the essentials. New York: Theme Medical Publishers Inc; 1999. p. 666–77.

Early Treatment Diabetic Retinopathy Study Research Group. Fundus photographic risk factors for progression of diabetic retinopathy ETDRS report number 12. Ophthalmology. 1991;98:823–33.

Alagoz C, et al. The Efficacy of intravitreal bevacizumab in vitreous hemorrhage of diabetic subjects. Turk J Ophthalmol. 2016;46(5):221.

Vander JF, Duker JS, Benson WE, et al. Long-term stability and visual outcome after favorable initial response of proliferative diabetic retinopathy to panretinal photocoagulation. Ophthalmology. 1991;98:1575–9.

Adamis AP, Miller JW, Bernal MT, et al. Increased vascular endothelial growth factor levels in the vitreous of eyes with proliferative diabetic retinopathy. Am J Ophthalmol. 1994;118:445–50.

Aiello LP, Avery RL, Arrigg PG, et al. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N Engl J Med. 1994;331:1480–7.

Malecaze F, Clamens S, Simorre-Pinatel V, et al. Detection of vascular endothelial growth factor messenger RNA and vascu- lar endothelial growth factor-like activity in proliferative dia- betic retinopathy. Arch Ophthalmol. 1994;112:1476–82.

El-Batarny AM. Intravitreal IVB treatment for retinal neovascularization and vitreous hemorrhage in proliferative diabetic retinopathy. Cin Ophthalmol. 2007;1:149–55.

Wilkinson-Berka JL. Vasoactive factors and diabetic retinopathy: vascular endothelial growth factor, cyclooxygenase-2 and nitric oxide. Curr Pharm Des. 2004;10:3331–48.

Parikh RN, et al. Intravitreal bevacizumab for the treatment of vitreous hemorrhage due to proliferative diabetic retinopathy. Am J Ophthalmol. 2017;176:194–202.

Spraul CW, Grossniklaus HE. Vitreous hemorrhage. Surv Ophthalmol. 1997;42:3–39.

Lucena DR. Ecografia em Retina. In: Guia para o cirurgião de seguimento anterior-retina e vítreo, ed Medica C, p41–44, Rio de Janeiro, 2006.

Diabetic Retinopathy Vitrectomy Study Research Group. Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy Two-year results of randomized trial, Diabetic retinopathy vitrectomy study report 2. Arch Ophthalmol. 1985;103:1644–52.

Avery RL. Regression of retina and iris neovascularization after intravitreal bevacizumab (Avastin) treatment. Retina. 2006;26:352–3.

Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006;26:275–8.

Jorge R, Costa RA, Calucci D, et al. Intravitreal bevacizumab (Avastin) for persistent new vessels in diabetic retinopathy (IBEPE study). Retina. 2006;26:1006–13.

Salam A, Mathew R, Sivaprasad S. Treatment of proliferative diabetic retinopathy with anti-VEGF agents. Acta Ophthalmol. 2011;89(5):405–11.

Chelala E, Nehme J, Rami HE, et al. Efficacy of Intravitreal Ranibizumabe Injections in the treatment of vitreous hemorrhage related to proliferative diabetic retinopathy. Retina. 2018;38:1127–33.

Lucena DR, Ribeiro JA, Costa RA, et al. Intraoperative bleeding during vitrectomy for diabetic tractional retinal detachment with versus without preoperative intravitreal bevacizumab (IbeTra study). Br J Ophthalmol. 2009;93(5):688–91.

Ahmadieh H, Shoeibi N, Entezari M, Monshizadeh R. Intra-vitreal bevacizumab for prevention of early postvitrectomy hemorrhage in diabetic patients: a randomized clinical trial. Ophthalmology. 2009;116(10):1943–8.

Huang YH, Yeh PT, Chen MS, Yang CH, Yang CM. Intravitreal bevacizumab and panretinal photocoagulation for proliferative diabetic retinopathy associated with vitreous hemorrhage. Retina. 2009;29:1134–40.

Schulze-Bonsel K, Feltgen N, Burau H, Hansen L, Bach M. Visual acuities “hand motion” and “counting fingers” can be quantified with the freiburg visual acuity test. Invest Ophthalmol Vis Sci. 2006;47(3):1236–40.

Jorge R, Oliveira RS, Messias A, Almeida FP, Strambe ML, Costa RA, Scott IU. Ranibizumab for retinal neovascularization. Ophthalmology. 2011;118:1004–5.

Chen E, Park CH. Use of intravitreal bevacizumab as a preoperative adjunct for tractional retinal detachment repair in severe proliferative diabetic retinopathy. Retina. 2006;26:699–700.

Avery RL, Pearlman J, Pieramici DJ, et al. Intravitreal bevacizumab (Avastin) in the treatment of proliferative diabetic retinopathy. Ophthalmology. 2006;113:1695.

Ishikawa K, Honda S, Tsukahara Y, et al. Preferable use of intravitreal bevacizumab as a pretreatment of vitrectomy for severe proliferative diabetic retinopathy. Eye (Lond). 2009;23:108e11.

Lucena DR, Ribeiro JAS, Costa RA, et al. Intraoperative bleeding during vitrectomy for diabetic tractional retinal detachment with versus without preoperative intravitreal bevacizumab (IbeTra Study). Br J Ophthalmol. 2009;93:688e91.

Arevalo JF, Maia M, Flynn HW Jr, et al. Tractional retinal detachment following intravitreal bevacizumab (Avastin) in patients with severe proliferative diabetic retinopathy. Br J Ophthalmol. 2008;92(2):213–6.

Campbell DG, Simmons RJ, Tolentino FI, McMeel JW. Glaucoma occurring after closed vitrectomy. Am J Ophthalmol. 1977;83(1):63–9.

Thông tin
Thông tin xuất bản

International Journal of Retina and Vitreous

Thông tin tác giả