Intravitreal bevacizumab for prevention of early postvitrectomy hemorrhage in diabetic patients: a randomized clinical trial
| Autor: | Ramin Monshizadeh, Hamid Ahmadieh, Nasser Shoeibi, Morteza Entezari |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Pars plana
Adult Male Vascular Endothelial Growth Factor A medicine.medical_specialty Visual acuity genetic structures Bevacizumab Adolescent medicine.medical_treatment Visual Acuity Vitrectomy Angiogenesis Inhibitors Antibodies Monoclonal Humanized law.invention Injections Young Adult Postoperative Complications Randomized controlled trial Double-Blind Method law Medicine Humans Prospective Studies Prospective cohort study Aged Diabetic Retinopathy business.industry Antibodies Monoclonal Diabetic retinopathy Middle Aged medicine.disease eye diseases Surgery Vitreous Hemorrhage Vitreous Body Ophthalmology medicine.anatomical_structure Treatment Outcome Vitreous hemorrhage Female sense organs medicine.symptom business medicine.drug |
| Zdroj: | Ophthalmology. 116(10) |
| ISSN: | 1549-4713 |
| Popis: | Objective To evaluate the effect of preoperative intravitreal bevacizumab (IVB) injection on the rate of early (≤4weeks) postvitrectomy hemorrhage in patients with proliferative diabetic retinopathy (PDR). Design Prospective, randomized, double-masked clinical trial. Participants Sixty-eight eyes of 68 patients undergoing pars plana vitrectomy for management of PDR complications. Methods Eligible eyes were assigned randomly to 1 of 2 groups: the IVB group received 1.25 mg intravitreal bevacizumab 1 week before surgery, and the control group underwent a sham procedure. Main Outcome Measures The primary outcome measure was the incidence of early postvitrectomy hemorrhage. Secondary outcome measures included changes in best-corrected visual acuity (BCVA) and IVB-related adverse events. Results Of 68 eyes, 35 and 33 eyes were in the IVB and control groups, respectively. In the intention-to-treat analysis, the incidence of postvitrectomy hemorrhage 1 week and 1 month after surgery was significantly lower in the IVB group compared with the control group ( P = 0.023 and P = 0.001, respectively). Mean BCVA improved from 1.88 logarithm of minimum angle of resolution (logMAR) units in both study groups before surgery to 0.91 logMAR units and 1.46 logMAR units 1 month after vitrectomy in the IVB and control groups, respectively ( P = 0.001). Resolution of vitreous hemorrhage was observed in 9 eyes (25.7%) after IVB injection, obviating the need for vitrectomy; the corresponding figure was 2 eyes (6.1%) in the control group ( P = 0.028). The per-protocol analysis included 16 eyes in the IVB group and 18 eyes in the control group; postvitrectomy hemorrhage occurred less frequently 1 week and 1 month after surgery in the IVB group compared with the control group ( P = 0.033 and P = 0.003, respectively). Mean improvement in BCVA 1 month after vitrectomy was −1.05 logMAR units in the IVB group and −0.42 logMAR units in the control group ( P = 0.004). No IVB-related complication was observed in the treatment group. Conclusions Intravitreal injection of bevacizumab 1 week before vitrectomy seems to reduce the incidence of early postvitrectomy hemorrhage in diabetic patients. The need for vitrectomy also may be decreased significantly in these cases. Financial Disclosure(s) The author(s) have no proprietary or commercial interest in any materials discussed in this article. |
| Databáze: | OpenAIRE |
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