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

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

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.

Study Overview

• Status: Completed
• Conditions: Proliferative Diabetic Retinopathy
• Intervention / Treatment: Drug: ranibizumab; Procedure: pars plana vitrectomy; Drug: sham

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ranibizumab; Intravitreal Injection of 0.5 mg ranibizumabone week before vitrectomy.	Drug: ranibizumab; intravitreal injection of 0.5 mg ranibizumab before vitrectomy; Other Names: Lucentis; 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.; Other Names: vitrectomy
Sham Comparator: control; Sham intravitreal injection one week 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.; Other Names: vitrectomy; Drug: sham; sham intravitreal injection before vitrectomy; Other Names: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
perioperative hemorrhage of the surgical eye	3 month

Secondary Outcome Measures

Outcome Measure	Time Frame
size of retinal non-perfusion area assessed by fluorescene angiography	3 month
macular retinal thickness assessed with optical coherance tomography	3 month
retinal vessel oxygen saturation measured with a retinal oximeter	3 months
best-corrected visual acuity	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications	other perioperative complications	3 months
surgical time		1 day
grade of surgical difficulty		1 day

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: 2014MEKY034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No