To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.
Primary Objective: To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy. Secondary Objective:To investigate ranibizumab's additional benefit on visual improvement, facilitation of surgery and postoperative outcomes in PDR-DME patients receiving vitrectomy. Study design: This study is a prospective, randomized, single-blinded, blank-controlled, multi-center clinical trial that requires vitrectomy for PDR-DME patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
142
Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3\~7 days before vitrectomy.
Patients will receive single sham injection 3\~7 days before vitrectomy.
Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina
Ningbo Eye Hospital
Ningbo, Zhejiang, China
Eye & Ent Hospital of Fudan University
Shanghai, China
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, China
Early postoperative vitreous haemorrhage
To compare the incidence of the early postoperative vitreous haemorrhage between two arms
Time frame: From day 1 to week 4 after the vitrectomy
Mean Best-corrected visual acuity (BCVA) at Month 3
To compare the changes from baseline BCVA to mean BCVA at month 3 between two arms.
Time frame: Month 3 after vitrectomy
Mean Best-corrected visual acuity (BCVA) at Month 6
To compare the changes from baseline BCVA to mean BCVA at month 6 between two arms.
Time frame: Month 6 after vitrectomy
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