This study investigates the hypothesis that ranibizumab injection given into the eye is a safe, efficacious and helping treatment option applied before surgical intervention of the proliferative diabetic retinal eye disorder.
This is a randomized, double blinded , controlled, two-center study assessing the feasibility, efficacy and safety of intravitreal ranibizumab injection applied as a preoperative adjunct treatment before vitrectomy surgery in severe proliferative diabetic retinopathy (PDR). Comparator arm consists of patients receiving standard vitrectomy alone with sham intravitreal injection preoperatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
ranibizumab 10mg/ml intravitreal injection, 0,05 ml
sham intravitreal injection before vitrectomy surgery
University of Debrecen, Medical and Health Science Center, Faculty of Medicine, Department of Ophthalmology
Debrecen, Hungary
Efficacy of preoperative intravitreal ranibizumab
Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy
Time frame: OP day
Change in BCVA.
Time frame: 6 months
Effect in anatomical changes.
Time frame: 3 ±1 days after injection
Safety.
Time frame: Over 6 months.
Retinal circulation integrity.
Evaluating the circulation of original retinal vessels, evaluating the size of proliferative vessels (size of leaking areas and number of leaking points measured by Fluorescein angiography )
Time frame: Month 1, 3, 6.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.