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Completed

NCT Number: NCT02857491

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

intravitreal injection of 0.5 mg ranibizumab before vitrectomy

Other names: Lucentis

sham

Drug

sham intravitreal injection before vitrectomy

Other names: control

pars plana vitrectomy

Procedure

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

Primary outcomes

  1. perioperative hemorrhage of the surgical eye

    Time frame: 3 month

Secondary outcomes

  1. size of retinal non-perfusion area assessed by fluorescene angiography

    Time frame: 3 month

  2. macular retinal thickness assessed with optical coherance tomography

    Time frame: 3 month

  3. retinal vessel oxygen saturation measured with a retinal oximeter

    Time frame: 3 months

  4. best-corrected visual acuity

    Time frame: 3 months

Other outcomes

  1. complications

    Time frame: 3 months

    other perioperative complications

  2. surgical time

    Time frame: 1 day

  3. grade of surgical difficulty

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 5, 2016
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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