Intravitreal injection of bevacizumab in primary vitrectomy to decrease the rate of retinal redetachment: A randomized pilot study (original) (raw)

Preoperative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy: Prospective Randomized Clinical Trial of the Pan-American Collaborative Retina Study (PACORES) Group*

American Journal of Ophthalmology, 2019

PURPOSE: To assess the effectiveness and safety of an intravitreal injection of 1.25 mg of bevacizumab (IVB) as a preoperative adjunct to small-gauge pars plana vitrectomy (PPV) compared to PPV alone in eyes with tractional retinal detachment (TRD) secondary to proliferative diabetic retinopathy (PDR). 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 exam including best corrected visual acuity (BCVA), color photos, optical coherence tomography (OCT) and fluorescein angiography (FA). Data were collected on intraoperative bleeding, total surgical time, early (<1 month) postoperative vitreous hemorrhage (VH), and mean change in BCVA at 12 months. P<0.05 was considered statistically significant. RESULTS: Two hundred and fourteen (214 eyes) patients 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=0.001). 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=0.001). Endodiathermy was necessary in 28 (27.4 %) eyes in the study group, compared with 75 (66.9 %) eyes in the control group (P=0.0001). Mean surgical time was 71.3±32.1 minutes in the study group and 83.6±38.7 minutes in the control group (P=0.061). CONCLUSION: Preoperative IVB seems to reduce intraoperative bleeding, improving surgical field visualization, and reducing intraoperative and postoperative complications.

Six-month visual outcome after pars plana vitrectomy in proliferative diabetic retinopathy with or without a single preoperative injection of intravitreal bevacizumab

International Ophthalmology, 2012

The purpose of this study is to evaluate the effect of a single preoperative injection of intravitreal bevacizumab (IVB) on visual outcome in patients undergoing pars plana vitrectomy (PPV) for proliferative diabetic retinopathy (PDR). Retrospective chart review of patients who underwent PPV for PDR and followed for at least 6 months after surgery. Patients who received a single IVB injection (1.25 mg in 0.05 ml) preoperatively were assigned to group A. Those who did not receive IVB were assigned to group B. The primary outcome measure was visual outcome at 6-month follow-up. The secondary outcomes were postoperative complications. At 6 months, visual acuity improved by at least 0.3 logMAR units in 70 (74.5 %) of the 94 eyes in group A versus 46 (52.9 %) of the 87 eyes in group B (p = 0.002). Postoperative vitreous hemorrhage occurred significantly less frequently in group A (6 eyes, 6.4 %) than in group B (14 eyes, 16.1 %; p = 0.037). The incidence of other postoperative complications did not differ significantly between the two groups. Preoperative use of bevacizumab improved the 6-month visual outcome in patients undergoing PPV for PDR and significantly reduced the occurrence of postoperative vitreous hemorrhage.

Intrasilicone oil injection of bevacizumab at the end of retinal reattachment surgery for severe proliferative vitreoretinopathy

Eye, 2014

Purpose To evaluate the role of bevacizumab injected into the silicone oil at the end of retinal reattachment surgery for rhegmatogenous retinal detachment (RRD) associated with severe proliferative vitreoretinopathy (PVR) for prevention of postoperative PVR and compare the results with those without intrasilicone injection. Methods In this prospective comparative interventional study, eyes with RRD with grade C PVR were included. Standard 20 gauge pars plana vitrectomy, and retinal reattachment was performed. In case group, 1.25 mg bevacizumab was injected into the silicone oil at the end of surgery. The rate of retinal redetachment associated with PVR was assessed. Results In all 38 eyes of 38 patients (19 cases and 19 controls) with a mean age of 46.6±18.3 years were studied. The two groups were matched for age, sex, preoperative visual acuity, presence of anterior and posterior PVR, extent of PVR, and history of previous retinal detachment surgery. Retinal redetachment with PVR occurred in nine (47.3%) and seven (36.8%) eyes in case and control groups, respectively (P ¼ 0.5). Extensive subretinal fibrous proliferations in addition to preretinal membranes occurred more in the case group (55.5 vs 14.3%). At final visit, visual acuity was similar between the two groups (1.6 ± 0.8 and 1.6 ± 0.6, respectively, P ¼ 0.9). Conclusion Intrasilicone injection of bevacizumab at the end of vitrectomy for RRD with severe PVR does not eliminate the risk of postoperative PVR.

Intravitreal Injection of Bevacizumab before Vitrectomy for Proliferative Diabetic Retinopathy

European Journal of Ophthalmology, 2009

Purpose. To evaluate the use of preoperative intravitreal bevacizumab (IVB) injection in patients undergoing pars plana vitrectomy for complications of proliferative diabetic retinopathy (PDR). Methods. In this prospective surgeon-masked randomized clinical trial, 40 eyes of 40 diabetic patients who were candidates for vitrectomy were randomly assigned to receive 2.5 mg IVB 3-5 days before operation (injected group) or no injection before operation (noninjected group). A preoperative complexity score (CS) was recorded. Best-corrected visual acuity, number of endodiathermy applications, backflush needle applications, duration of surgery, and postoperative vitreous hemorrhage were recorded. results. Twenty-two patients with a CS of 6±0.95 in the injected group and 18 patients with a CS of 5.7±1.1 in the noninjected group (p=0.3) were studied. Postoperative visual acuities were significantly better than preoperative visual acuities. Preoperative and 3-month postoperative visual acuities were the same for both groups; however, in the last follow-up examinations (mean 7± 3.6 months) the injected group had better visual acuities than the noninjected group (1.1±0.4 and 1.4±0.3 logMAR, respectively, p=0.006). Mean surgical time was 62±57.3 minutes in the injected group vs 95.5±36 minutes in the noninjected group (p=0.03): endodiathermy applications 6.0±4.3 vs 11.0±5.8 (p=0.004), backflush cannula applications 11.0±7.2 vs 18.1±7.8 (p=0.004). In non-silicone-filled eyes, no patient in the injected group developed significant postoperative vitreous hemorrhage obscuring the fundus details, while 7 eyes of noninjected eyes had this complication (p=0.01). ConClusions. IVB injection before vitrectomy for PDR facilitates the surgery, and may decrease the rate of postoperative vitreous hemorrhage and improve the visual acuity results of the operation.

Intravitreal bevacizumab for surgical treatment of severe proliferative diabetic retinopathy

Graefe's Archive for Clinical and Experimental Ophthalmology, 2010

Background The purpose of this study is to evaluate the role, the safety and the effectiveness of intravitreal bevacizumab (IVB) injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy (PDR). Design Case-Control Study Methods Randomized controlled trial performed on 72 eyes of 68 patients affected by vitreous haemorrhage (VH) and tractional retinal detachment (TRD), which occurred as a consequence of active proliferative diabetic retinopathy (PDR). We randomly assigned eligible patients in a 1: 1: 1 ratio to receive a sham injection or an intravitreal injection of 1.25 mg of bevacizumab, either 7 or 20 days before the vitrectomy. In order to obtain three homogeneous groups of surgical complexity, we assigned to the following preoperative parameters a score from 0 to 3: a) vitreous haemorrhage, b) prior retinal laser-photocoagulation, c) morphological types of retinal detachment such as focal, hammock, central diffuse, table-top. Complete ophthalmic examinations and color fundus photography were performed at baseline and 1, 6, 12, and 24 weeks after the surgery. Main outcome measures Intraoperative management, safety, efficacy of IVB at different time injection as an adjunct to vitrectomy in the management of severe PDR Results Group A (sham injection): intraoperative bleeding occurred in 19 cases (79.1%), the use of endodiathermy was necessary in 13 patients (54.1%), relaxing retinotomy was performed on one patient (4.1%), and in four cases (16.6%) iatrogenic retinal breaks occurred. The surgical mean time was 84 minutes (SD 12 minutes). Group B (bevacizumab administered 7 days before vitrectomy): intraoperative bleeding occurred in two cases (8.3%) and the use of endodiathermy was necessary in two patients (8.3%). No iatrogenic breaks occurred during the surgery. The surgical mean time was 65 minutes (SD 18 minutes). Group C (bevacizumab administered 20 days before vitrectomy): intraoperative bleeding occurred in three cases (12.5%), the use of endodiathermy was necessary in three patients (1.5%), and an iatrogenic break occurred in one patient (4.1%) while the delamination of fibrovascular tissue was being performed. The surgical mean time was 69 minutes (SD 21 minutes). The average difference in the surgical time was statistically significant between group A and group B (p=0.025), and between group A and group C (p=0.031). At the end of the surgery, the retina was completely attached in all eyes. At the 6-month follow-up, we observed the development of tractional retinal detachment (TRD) in one out of 24 patients from group C (4%). Conclusions A preoperative intravitreal injection of bevacizumab may represent a new strategy for the surgical treatment of severe PDR by reducing retinal and iris neovascularization: this would make surgery much easier and safer, thus improving the anatomical and functional prognosis. According to our study, the best surgical results are achieved performing the IVB 7 days preoperatively.

Effect of Serial Intrasilicone Oil Bevacizumab Injections in Eyes with Recurrent Proliferative Vitreoretinopathy Retinal Detachment

American journal of ophthalmology, 2015

To investigate the effect of serial intrasilicone oil bevacizumab injections (1.25mg/0.05mL) on visual acuity (VA) and anatomic outcomes in eyes undergoing proliferative vitreoretinopathy (PVR)-related retinal detachment (RD) repair. Prospective, non-randomized, historical-control pilot study. Setting: Tertiary care center. Non-diabetic eyes undergoing pars plana vitrectomy (PPV) and silicone oil tamponade with or without scleral buckling procedure (SBP) for recurrent RD due to PVR. Intrasilicone oil injection of 1.25mg bevacizumab was performed intraoperatively and at postoperative months 1, 2, and 3. Retinal reattachment rate, final VA, and rate of epiretinal membrane (ERM) formation at month 6. Twenty eyes of 20 patients were enrolled and compared to a historical control group comprised of 35 age- and gender- matched controls. In the study group, logMAR VA improved from mean 1.78±0.43 (Snellen 20/1205) to 1.43±0.70 (Snellen 20/538, p = 0.04), retinal reattachment was achieved in ...

Intravitreal bevacizumab prior to vitrectomy for proliferative diabetic retinopathy: a systematic review

Therapeutic Advances in Ophthalmology, 2021

Background: Diabetic retinopathy is a leading cause of visual loss in the working population. Pars plana vitrectomy has become the mainstream treatment option for severe proliferative diabetic retinopathy (PDR) associated with significant vitreous haemorrhage and/or tractional retinal detachment. Despite the advances in surgical equipment, diabetic vitrectomy remains a challenging operation, requiring advanced microsurgical skills, especially in the presence of tractional retinal detachment. Preoperative intravitreal bevacizumab has been widely employed as an adjuvant to ease surgical difficulty and improve postoperative prognosis.Aims: This study aims to assess the effectiveness of preoperative intravitreal bevacizumab in reducing intraoperative complications and improving postoperative outcomes in patients undergoing vitrectomy for the complications of PDR. Methods: A literature search was conducted using the PubMed, Cochrane, and ClinicalTrials.gov databases to identify all relat...

Effect of Bevacizumab Injection before Vitrectomy on Intravitreal Hemorrhage in Pseudophakic Patients with Proliferative Diabetic Retinopathy

Ophthalmology and Eye Diseases, 2013

We evaluated the effect of intravitreal bevacizumab (IVB) injection before pars plana vitrectomy (PPV) on intravitreal hemorrhage (VH) during and after vitrectomy for postoperative the first day and the first month in pseudophakic patients with proliferative diabetic retinopathy (PDR). This retrospective study was performed on 44 eyes of 44 patients who underwent vitrectomy for PDR. Patients were divided into PPV (n = 22 eyes) and PPV + IVB (n = 22 eyes) groups. Injection of bevacizumab (1.25 mg/0.05 mL) was performed 3 days before vitrectomy. Outcomes of visual acuity as well as intraoperative and postoperative VH were compared between the two groups. One month after surgery, visual acuity improved in PPV and PPV + IVB groups (P = 0.005, P = 0.006), respectively. There was no difference between the two groups in best corrected visual acuity at baseline and after vitrectomy (P = 0.71). Intraoperative bleeding into the vitreous was recorded in 14 (63.6%) cases in the PPV group and in 7 (31.8%) cases in the PPV + IVB group. The first month, intravitreal hemorrhage was recorded in six patients in the PPV group and in two patients in the PPV + IVB group (P = 0.03). The mean pre-postoperative central macular thickness was similar in both groups. Intravitreal injection of IVB before vitrectomy decreased the rate of VH at the time of surgery and at the first postoperative month in patients with PDR.

Effect of preoperative intravitreal bevacizumab injection on visual outcome in vitrectomy for diabetic vitreous haemorrhage

2017

Objective: To evaluate the effect and safety of bevacizumab pretreatment on visual acuity after pars plan vitrectomy for diabetic vitreous Haemorrhage. Study design: Prospective, cohort study. Setting: Ophthalmology unit III, Mayo Hospital, King Edward Medical University Lahore Pakistan. Duration: The study was carried out in one year, from 01, January 2013 to 31, December 2013. Materials and methods: A total of sixty patients diagnosed with dense non clearing diabetic vitreous haemorrhage fulfilling inclusion and exclusion criteria were identified and registered. In group A, thirty (30) eyes were treated preoperatively with Bevacizumab and in group B thirty (30) eyes were not treated with Bevacizumab before vitrectomy for diabetic vitreous haemorrhage. All patients were followed for post operative outcome measures including best corrected visual acuity (BCVA), post operative vitreous haemorrhage, and other complications for three to six months. Results: At six (06) months foll...

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

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 rand...