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

NCT ID: NCT02857491

Last Updated: 2017-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Proliferative Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ranibizumab

Intravitreal Injection of 0.5 mg ranibizumabone week before vitrectomy.

Group Type EXPERIMENTAL

ranibizumab

Intervention Type DRUG

intravitreal injection of 0.5 mg ranibizumab before vitrectomy

pars plana vitrectomy

Intervention Type PROCEDURE

surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina.

control

Sham intravitreal injection one week before vitrectomy.

Group Type SHAM_COMPARATOR

sham

Intervention Type DRUG

sham intravitreal injection before vitrectomy

pars plana vitrectomy

Intervention Type PROCEDURE

surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina.

Interventions

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ranibizumab

intravitreal injection of 0.5 mg ranibizumab before vitrectomy

Intervention Type DRUG

sham

sham intravitreal injection before vitrectomy

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Other Intervention Names

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Lucentis control vitrectomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Lin Lu

Director of Fundus Disease Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lin Lu

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2014MEKY034

Identifier Type: -

Identifier Source: org_study_id