Overview

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

Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
0
Participant gender:
All
Summary
To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator:
Novartis
Treatments:
Ranibizumab
Criteria
Inclusion Criteria:

1. Ageā‰„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