Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema
Prospective, Single-blind, Randomised, Controlled, Multi-centre Study to Evaluate the Benefit of Ranibizumab as an Adjunctive Therapy to Vitrectomy for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Oedema
1 other identifier
interventional
142
1 country
3
Brief Summary
To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2020
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2020
CompletedFirst Posted
Study publicly available on registry
July 9, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJuly 9, 2020
July 1, 2020
1.2 years
July 5, 2020
July 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Early postoperative vitreous haemorrhage
To compare the incidence of the early postoperative vitreous haemorrhage between two arms
From day 1 to week 4 after the vitrectomy
Secondary Outcomes (2)
Mean Best-corrected visual acuity (BCVA) at Month 3
Month 3 after vitrectomy
Mean Best-corrected visual acuity (BCVA) at Month 6
Month 6 after vitrectomy
Study Arms (2)
Ranibizumab
EXPERIMENTALSingle intravitreal injection of ranibizumab (0.5 mg) 3\~7 days before vitrectomy
Sham injection
SHAM COMPARATORSham injection 3\~7 days before vitrectomy
Interventions
Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3\~7 days before vitrectomy.
Patients will receive single sham injection 3\~7 days before vitrectomy.
Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina
Eligibility Criteria
You may qualify if:
- Age≥18 years old;
- Type I or II diabetes mellitus, clinically diagnosed as diabetic macular edema
- 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
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
You may not qualify if:
- Pregnancy or lactation;
- History of stroke, peripheral vascular disease, angina or myocardial infarction within six months
- Intraocular treatment with corticosteroids, anti-vascular endothelium growth factor or intraocular surgery within 45 days preceding baseline;
- Clinically confirmed intraocular pressure (IOP) \>=21 mmHg, uncontrolled glaucoma or iris neovascularization in either eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Ningbo Eye Hospital
Ningbo, Zhejiang, 315012, China
Eye & Ent Hospital of Fudan University
Shanghai, 2000831, China
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, 2000892, China
Related Publications (3)
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.
PMID: 19584650RESULTZhao 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.
PMID: 21278146RESULTComyn 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.
PMID: 28498374RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peiquan Zhao
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2020
First Posted
July 9, 2020
Study Start
September 1, 2020
Primary Completion
December 1, 2021
Study Completion
June 1, 2022
Last Updated
July 9, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share