Comparison of Surgery Outcome Between Preoperative IVR and Intraoperative IVR in PPV for PDR

NCT05408416 | Completed DMC

• 1 other identifier: PekingUPHJinfeng Qu
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Proliferative diabetic retinopathy (PDR) is the most common causes of irreversible blindness in diabetic retinopathy (DR).Intravitreal injection of anti-VEGF drugs is a good adjunct to vitreous surgery for severe PDR. Some studies have confirmed that the application of anti-VEGF drugs before vitrectomy for PDR patients can reduce the difficulty of surgery and improve postoperative best corrected visual acuity (BCVA), but very few researches focused on the injections of anti-VEGF during surgery.Therefore, investigators carry out this clinical trial to compare the effects of preoperative and intraoperative intravitreal injections of ranibizumab (IVR) on vitrectomy outcomes for PDR patients.One group receive ranibizumab injection (0.5mg/0.05ml) 3-5 days before vitrectomy. Another group receive ranibizumab injection (0.5mg/0.05ml) at the end of vitrectomy. Intraoperative and postoperative indices are collected for further comparison.Investigators enroll PDR patients whose baseline characteristics including age, sex, BMI, type of diabetes, HbA1c level, duration of DM, hypertension, previous history of laser photocoagulation, status of lens, indication for surgery, baseline BCVA, IOP, baseline CRT and extent of VAG are comparable.The enrolled eyes are randomly assigned according to the Central Randomization System with a ratio of 1:1 to preoperative IVR group and intraoperative IVR group. Intraoperative including surgery time, intraoperative bleeding, intraocular electrocoagulation use, iatrogenic retinal breaks, relaxing retinotomy and silicone oil tamponade, and postoperative indices including postoperative best-corrected visual acuity (BCVA), central retinal thickness (CRT), postoperative vitreous hemorrhage (VH), neovascular glaucoma (NVG), recurrent retinal detachment, postoperative fibrovascular proliferation progression and reoperationare collected for further comparison.

Conditions

Proliferative Diabetic Retinopathy

Keywords

pars plana vitrectomy; ranibizumab; preoperative intravitreal injection; intraoperative intravitreal injection

Outcome Measures

Primary Outcomes (2)

• best-corrected visual acuity (BCVA)

  every visit time

  from preoperation to 3 months follow-up

• central retinal thickness

  every visit time

  from preoperation to 3 months follow-up

Secondary Outcomes (11)

• surgery time

  during surgery

• intraoperative bleeding

  during surgery

• intraocular electrocoagulation use

  during surgery

• iatrogenic retinal breaks

  during surgery

• relaxing retinotomy

  during surgery

Study Arms (2)

preoperative group

ACTIVE COMPARATOR

PDR patients who received ranibizumab injection (0.5mg/0.05ml) 3-5 days before vitrectomy were assigned to preoperative group

Procedure: preoperative group and intraoperative group

intraoperative group

EXPERIMENTAL

PDR patients who received ranibizumab injection (0.5mg/0.05ml) at the end of vitrectomy were assigned to intraoperative group

Procedure: preoperative group and intraoperative group

Interventions

preoperative group and intraoperative group PROCEDURE

ranibizumab injection (0.5mg/0.05ml) 3-5 days before vitrectomy or ranibizumab injection (0.5mg/0.05ml) at the end of vitrectomy

intraoperative group; preoperative group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18 years or more with type 1 or 2 diabetes who were clinically diagnosed with PDR;
• persistent VH for more than 1 month or recurrent VH with or without panretinal photocoagulation (PRP);
• TRD detected by indirect ophthalmoscope or B-scan ultrasonography.

You may not qualify if:

• previous vitrectomy or intravitreal injection in the study eyes;
• eyes with any ocular disease that may hinder visual improvement other than PDR, such as optic atrophy or macular hole;
• poor control of diabetes mellitus (DM) with hemoglobin A1c (HbA1c) \> 12%;
• history of thromboembolic events (including cerebral vascular infarctions or myocardial infarctions) or coagulation system disorders or receiving anticoagulant or antiplatelet therapy;
• eyes given gas tamponade or additional treatment during follow-up periods.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

People's Hospital of Peking University

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (11)

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  PMID: 30060300 BACKGROUND

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  PMID: 20168268 BACKGROUND

• Bressler SB, Qin H, Melia M, Bressler NM, Beck RW, Chan CK, Grover S, Miller DG; Diabetic Retinopathy Clinical Research Network. Exploratory analysis of the effect of intravitreal ranibizumab or triamcinolone on worsening of diabetic retinopathy in a randomized clinical trial. JAMA Ophthalmol. 2013 Aug;131(8):1033-40. doi: 10.1001/jamaophthalmol.2013.4154.

  PMID: 23807371 BACKGROUND

• Ehrlich R, Harris A, Ciulla TA, Kheradiya N, Winston DM, Wirostko B. Diabetic macular oedema: physical, physiological and molecular factors contribute to this pathological process. Acta Ophthalmol. 2010 May;88(3):279-91. doi: 10.1111/j.1755-3768.2008.01501.x. Epub 2010 Mar 11.

  PMID: 20222885 BACKGROUND

• Wang X, Wang G, Wang Y. Intravitreous vascular endothelial growth factor and hypoxia-inducible factor 1a in patients with proliferative diabetic retinopathy. Am J Ophthalmol. 2009 Dec;148(6):883-9. doi: 10.1016/j.ajo.2009.07.007. Epub 2009 Oct 17.

  PMID: 19837381 BACKGROUND

• Ferenchak K, Duval R, Cohen JA, MacCumber MW. Intravitreal bevacizumab for postoperative recurrent vitreous hemorrhage after vitrectomy for proliferative diabetic retinopathy. Retina. 2014 Jun;34(6):1177-81. doi: 10.1097/IAE.0000000000000058.

  PMID: 24457977 BACKGROUND

• 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.

  PMID: 28498374 BACKGROUND

• Simunovic MP, Maberley DA. ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY FOR PROLIFERATIVE DIABETIC RETINOPATHY: A Systematic Review and Meta-Analysis. Retina. 2015 Oct;35(10):1931-42. doi: 10.1097/IAE.0000000000000723.

  PMID: 26398553 BACKGROUND

• di Lauro R, De Ruggiero P, di Lauro R, di Lauro MT, Romano MR. Intravitreal bevacizumab for surgical treatment of severe proliferative diabetic retinopathy. Graefes Arch Clin Exp Ophthalmol. 2010 Jun;248(6):785-91. doi: 10.1007/s00417-010-1303-3. Epub 2010 Feb 5.

  PMID: 20135139 BACKGROUND

• Ren X, Bu S, Zhang X, Jiang Y, Tan L, Zhang H, Li X. Safety and efficacy of intravitreal conbercept injection after vitrectomy for the treatment of proliferative diabetic retinopathy. Eye (Lond). 2019 Jul;33(7):1177-1183. doi: 10.1038/s41433-019-0396-0. Epub 2019 Mar 14.

  PMID: 30872770 BACKGROUND

• Li S, Tang J, Han X, Wang Z, Zhang L, Zhao M, Qu J. Prospective Comparison of Surgery Outcome Between Preoperative and Intraoperative Intravitreal Injection of Ranibizumab for Vitrectomy in Proliferative Diabetic Retinopathy Patients. Ophthalmol Ther. 2022 Oct;11(5):1833-1845. doi: 10.1007/s40123-022-00550-7. Epub 2022 Jul 29.

  PMID: 35904708 DERIVED

Study Officials

• Jinfeng Qu, MD

  Peking University People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: September 1, 2021
• Primary Completion: May 29, 2022
• Study Completion: May 29, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)