Intravitreal Injection of Ranibizumab Versus Sham Before Vitrectomy in Patients With Proliferative Diabetic Retinopathy

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857491
• Other study ID #: 2014MEKY034
• Status: Completed
• Phase: N/A
• First received: July 27, 2016
• Last updated: October 12, 2017
• Start date: July 2014
• Est. completion date: September 30, 2017

Study information

• Verified date: October 2017
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• type I or type II diabetes

• there is clear indications for vitrectomy due to proliferative membrane in the vitreoretinal interface, mild hemorrhage, or tractional retinal detachment

• retinal large vessels could be detected within one PD away from the edge of optic disc by OCT

• microcurculation could be detected by FFA in at least one quadrant

• the patient could tolerant FFA examination

Exclusion Criteria:

• a history of vitrectomy or scleral bucke in the included eye

• retinal laser photocoagulation treatment within 90 days in the included eye

• anti-VEGF treatment with 90 days in either eye

• there is cocurrent neovascular glaucoma in the included eye

• any reason that might hinde the procedure of vitrectomy, FFA OCT or the observation of ocular fudus

• a history of cere-brovascular accident or heart stroke

• renal failure

• could not attend follow up regularly

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• ranibizumab
intravitreal injection of 0.5 mg ranibizumab before vitrectomy
• sham
sham intravitreal injection before vitrectomy

Procedure:
• pars plana vitrectomy
surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	complications	other perioperative complications	3 months
Other	surgical time		1 day
Other	grade of surgical difficulty		1 day
Primary	perioperative hemorrhage of the surgical eye		3 month
Secondary	size of retinal non-perfusion area assessed by fluorescene angiography		3 month
Secondary	macular retinal thickness assessed with optical coherance tomography		3 month
Secondary	retinal vessel oxygen saturation measured with a retinal oximeter		3 months
Secondary	best-corrected visual acuity		3 months