Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04464694
• Other study ID #: XH-20-011
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2020
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Peiquan Zhao
• Phone: 13311620396
• Email: Zhaopeiquan[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 142
• Est. completion date: June 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Ranibizumab
Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3~7 days before vitrectomy.

Other:
• Sham injection
Patients will receive single sham injection 3~7 days before vitrectomy.

Procedure:
• 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

Locations

Country	Name	City	State
China	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

Sponsors (2)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Novartis

Country where clinical trial is conducted

China, 

References & Publications (3)

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 RaDiV — View 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):9 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Best-corrected visual acuity (BCVA) at Month 3	To compare the changes from baseline BCVA to mean BCVA at month 3 between two arms.	Month 3 after vitrectomy
Secondary	Mean Best-corrected visual acuity (BCVA) at Month 6	To compare the changes from baseline BCVA to mean BCVA at month 6 between two arms.	Month 6 after vitrectomy