Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema
NCT ID: NCT04464694
Last Updated: 2020-07-09
Study Results
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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UNKNOWN
PHASE4
142 participants
INTERVENTIONAL
2020-09-01
2022-06-01
Brief Summary
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Detailed Description
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Secondary Objective:To investigate ranibizumab's additional benefit on visual improvement, facilitation of surgery and postoperative outcomes in PDR-DME patients receiving vitrectomy.
Study design: This study is a prospective, randomized, single-blinded, blank-controlled, multi-center clinical trial that requires vitrectomy for PDR-DME patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ranibizumab
Single intravitreal injection of ranibizumab (0.5 mg) 3\~7 days before vitrectomy
Ranibizumab
Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3\~7 days before vitrectomy.
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
Sham injection
Sham injection 3\~7 days before vitrectomy
Sham injection
Patients will receive single sham injection 3\~7 days before vitrectomy.
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
Interventions
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Ranibizumab
Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3\~7 days before vitrectomy.
Sham injection
Patients will receive single sham injection 3\~7 days before vitrectomy.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Type I or II diabetes mellitus, clinically diagnosed as diabetic macular edema
3. Diagnosed as proliferative diabetic retinopathy and pas plana vitrectomy (PPV) is required to undergo due to non-absorbent vitreous hemorrhage (VH), fibrovascular proliferation with vitreoretinal adhesions or tractional retinal detachment (TRD); or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation; as well as other indications of PPV at the investigator's discretion
4. Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Exclusion Criteria
2. History of stroke, peripheral vascular disease, angina or myocardial infarction within six months
3. Intraocular treatment with corticosteroids, anti-vascular endothelium growth factor or intraocular surgery within 45 days preceding baseline;
4. Clinically confirmed intraocular pressure (IOP) \>=21 mmHg, uncontrolled glaucoma or iris neovascularization in either eye
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Peiquan Zhao
Role: PRINCIPAL_INVESTIGATOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Ningbo Eye Hospital
Ningbo, Zhejiang, China
Eye & Ent Hospital of Fudan University
Shanghai, , China
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Lo WR, Kim SJ, Aaberg TM Sr, Bergstrom C, Srivastava SK, Yan J, Martin DF, Hubbard GB 3rd. Visual outcomes and incidence of recurrent vitreous hemorrhage after vitrectomy in diabetic eyes pretreated with bevacizumab (avastin). Retina. 2009 Jul-Aug;29(7):926-31. doi: 10.1097/IAE.0b013e3181a8eb88.
Zhao LQ, Zhu H, Zhao PQ, Hu YQ. A systematic review and meta-analysis of clinical outcomes of vitrectomy with or without intravitreal bevacizumab pretreatment for severe diabetic retinopathy. Br J Ophthalmol. 2011 Sep;95(9):1216-22. doi: 10.1136/bjo.2010.189514. Epub 2011 Jan 27.
Comyn O, Wickham L, Charteris DG, Sullivan PM, Ezra E, Gregor Z, Aylward GW, da Cruz L, Fabinyi D, Peto T, Restori M, Xing W, Bunce C, Hykin PG, Bainbridge JW. Ranibizumab pretreatment in diabetic vitrectomy: a pilot randomised controlled trial (the RaDiVit study). Eye (Lond). 2017 Sep;31(9):1253-1258. doi: 10.1038/eye.2017.75. Epub 2017 May 12.
Other Identifiers
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XH-20-011
Identifier Type: -
Identifier Source: org_study_id
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