Clinical trial NCT04464694: Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Proliferative Diabetic Retinopathy
Diabetic Macular Edema
Keywords: PDR
DME
ranibizumab
vitrectomy
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2020-07-09
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.

Detailed description: Primary Objective: To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.

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.

Eligibility criteria: Inclusion Criteria:

1. Age≥18 years old;
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:

1. Pregnancy or lactation;
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

Primary outcomes:
measure: Early postoperative vitreous haemorrhage
timeFrame: From day 1 to week 4 after the vitrectomy
Secondary outcomes:
measure: Mean Best-corrected visual acuity (BCVA) at Month 3
timeFrame: Month 3 after vitrectomy
measure: Mean Best-corrected visual acuity (BCVA) at Month 6
timeFrame: Month 6 after vitrectomy
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo Eye Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Eye & Ent Hospital of Fudan University
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Peiquan Zhao
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.