RecruitingPhase 3ACTRN12618000697280

Evaluation of the evolution of patients with vitreous hemorrhage caused by proliferative diabetic retinopathy subjected to intravitreal injection of antivascular endothelial growth factor (bevacizumab)


Sponsor

Hospital Oftalmológico de Sorocaba

Enrollment

60 participants

Start Date

May 30, 2017

Study Type

Interventional

Conditions

Summary

The microvascular complications of diabetes mellitus in the retina, defined as diabetic retinopathy (RD), constitute one of the main causes of blindness of the economically active population in Brazil and the world. Macular edema is the main cause of low visual acuity, however the proliferative form of RD is that it relates more frequently to severe visual loss. The presence of vitreous hemorrhage in patients with proliferative diabetic retinopathy is one of the main causes of severe visual acuity low in these patients. Vitreous hemorrhage that evolves without spontaneous absorption can significantly affect visual rehabilitation and require additional surgical procedures for improvement of the vision. The growth factor endothelial (VEGF) is expressed in high levels in the retina of diabetic retinopathy patients and are directly related to the formation of new vessels. By promoting a leukocyte migration and adhesion on the wall of vascular endothelial cells, increases vascular permeability and angiogenesis, with consequent progression of diabetic retinopathy. Inhibition of vascular growth factor may induce proliferative diabetic retinopathy regression and combat the exuding phenomenon. Bevacizumab (Avastin; Genentech, INC, South San Francisco, CA) is a monoclonal recombinant antibody against VEGF. Intravitreal injections of bevacizumab has been widely used in the treatment of different manifestations of proliferative diabetic retinopathy, such as progressive retinopathy active, before or combined with vitrectomy via pars plana (VVPP), severe retinal neovascularization or as a preoperative adjuvant to facilitate the surgery of VVPP. The vitreous hemorrhage presents itself as an evolution of this rigged angiogenesis process. The VVPP is the gold standard treatment for vitreous hemorrhage with or without tractional retinal detachment secondary proliferative diabetic retinopathy. Despite the VVPP having a high anatomical success rate, this procedure may be associated with surgery induced complications such as recurring vitreous hemorrhage, neovascular glaucoma, tractional retinal detachment and cataract. Such complications can compromise visual results. Moreover, a significant increase in the monetary cost of treatment. Until the present moment, there are few works that aims to evaluate whether patients presenting vitreous hemorrhage without retinal detachment, when subjected to VEGF intravitreal injections, has higher rates of spontaneous reabsorption of hemorrhage with consequent reduction in the need for surgery indication.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Diabetic patients Type 1 or type 2 with worsening of visual acuity (better corrected visual acuity less than or equal to 20/40) caused by vitreous hemorrhage with evolution without improvement of at least 30 days.

Exclusion Criteria6

  • Presence of tractional retinal detachment evidenced by ultrasound
  • Ocular inflammation or active infection (conjunctivitis, keratitis, swollen, scleritis, endophthalmitis)
  • Prior treatment with Antiangiogênico with less than 30 days
  • Vitrectomy via pars plane prior
  • Concomitant retinal disease that may interfere with the analysis of the final results ( macular hole, venous occlusion, AMD)
  • Known sensitivity to the drug used in the study

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Interventions

intravitreal injection of antivascular endothelial growth factor (bevacizumab) - 1,25 mg (0,05 mL) performed by ophthalmologist Initial injection must be given on the day of randomization. Follow-up

intravitreal injection of antivascular endothelial growth factor (bevacizumab) - 1,25 mg (0,05 mL) performed by ophthalmologist Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks (based on the time recommended for treatment of other ocular pathologies with bevacizumab) with a maximum of 6 injections provided and a minimum of 3 injections ( if criteria for deferral are met, that is reabsorption of vitreous hemorrhage that allows photocoagulation) until six months of follow-up,


Locations(1)

São Paulo/Sorocaba, Brazil

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