Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060, China
NCT Number: NCT02857491
Certain percent of the eyes with proliferative diabetic retinopathymay require pars plana vitrectomy (PPV) due to vitreous haemorrhage, proliferative membrane, and tractional retinal detachment. This study will compare intravitreal injection of anti-vascular endothelial growth factor (ranibizumab) versus sham injection before vitrectomy for PDR. The main focus is to see if pre-operative injection of ranibizuman can reduce peri-operative hemorrahge related complications.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510060, China
Eyes responding to panretinal photocoagulation can remain stable for decades, but incomplete responses and relapses can occur in a certain percent of diabetic patients showing as proliferative diabetic retinopathy. At present vitrectomy is the main intervention for those eyes with vitreous hemorrhage, proliferative membrane, and tractional retinal detachment. And the surgical procedure might be complicated because of intraoperative bleeding. And post-operative complications might be also involved. Perioperative use of intraocular anti-VEGF might be associated with less hemorrhage related complications and better visula acuity. This study will compare intravitreal injection of anti-vascular endothelial growth factor (ranibizumab) versus sham injection one week before surgery. The investigators tried to make sure whether pre-operative injection of ranibizuman can reduce reduce intra-operative bleeding, reduce the frequency of using endodiathermy, decrease surgical time, improve microcurculation of retina, and elevte best-corrected visual acuity.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intravitreal injection of 0.5 mg ranibizumab before vitrectomy
Other names: Lucentis
sham intravitreal injection before vitrectomy
Other names: control
surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina.
Other names: vitrectomy
Time frame: 3 month
Time frame: 3 month
Time frame: 3 month
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
other perioperative complications
Time frame: 1 day
Time frame: 1 day
Sun Yat-sen University
Other
Comparison of Intravitreal Injection of Ranibizumab Versus Sham Injection Before Vitrectomy in Patients With Proliferative Diabetic Retinopathy: a Single-center, Prospective Double-blinded Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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