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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Diabetic Macular Edema; Proliferative Diabetic Retinopathy

Treatments: Drug: Ranibizumab; Procedure: Pars plana vitrectomy; Other: Sham injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04464694

XH-20-011

Details and patient eligibility

About

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

Full 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.

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

Ranibizumab

Experimental group

Description:

Single intravitreal injection of ranibizumab (0.5 mg) 3\~7 days before vitrectomy

Treatment:

Procedure: Pars plana vitrectomy

Drug: Ranibizumab

Sham injection

Sham Comparator group

Description:

Sham injection 3\~7 days before vitrectomy

Treatment:

Other: Sham injection

Procedure: Pars plana vitrectomy