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

Phase 4

• Conditions: Proliferative Diabetic Retinopathy; Diabetic Macular Edema
• Interventions: Other: Sham injection; Drug: Ranibizumab; Procedure: Pars plana vitrectomy

• Registration Number: NCT04464694
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-05
• Study First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-07
• Study First Posted: 2020-07-09
• Last Update Posted: 2020-07-09
• Study Start: 2020-09-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham injection	Sham injection	Sham injection 3\~7 days before vitrectomy
Ranibizumab	Pars plana vitrectomy	Single intravitreal injection of ranibizumab (0.5 mg) 3\~7 days before vitrectomy
Sham injection	Pars plana vitrectomy	Sham injection 3\~7 days before vitrectomy
Ranibizumab	Ranibizumab	Single intravitreal injection of ranibizumab (0.5 mg) 3\~7 days before vitrectomy

Primary Outcome Measures

Name	Time	Method
Early postoperative vitreous haemorrhage	From day 1 to week 4 after the vitrectomy	To compare the incidence of the early postoperative vitreous haemorrhage between two arms

Secondary Outcome Measures

Name	Time	Method
Mean Best-corrected visual acuity (BCVA) at Month 6	Month 6 after vitrectomy	To compare the changes from baseline BCVA to mean BCVA at month 6 between two arms.
Mean Best-corrected visual acuity (BCVA) at Month 3	Month 3 after vitrectomy	To compare the changes from baseline BCVA to mean BCVA at month 3 between two arms.

Trial Locations

Locations (3)

Eye & Ent Hospital of Fudan University; 🇨🇳 Shanghai, China

Ningbo Eye Hospital; 🇨🇳 Ningbo, Zhejiang, China

Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, China