Status:
UNKNOWN
Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Novartis
Conditions:
Proliferative Diabetic Retinopathy
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ranibizu...
Eligibility Criteria
Inclusion
- Age≥18 years old;
- Type I or II diabetes mellitus, clinically diagnosed as diabetic macular edema
- 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
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Exclusion
- Pregnancy or lactation;
- History of stroke, peripheral vascular disease, angina or myocardial infarction within six months
- Intraocular treatment with corticosteroids, anti-vascular endothelium growth factor or intraocular surgery within 45 days preceding baseline;
- Clinically confirmed intraocular pressure (IOP) \>=21 mmHg, uncontrolled glaucoma or iris neovascularization in either eye
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04464694
Start Date
September 1 2020
End Date
June 1 2022
Last Update
July 9 2020
Active Locations (3)
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1
Ningbo Eye Hospital
Ningbo, Zhejiang, China, 315012
2
Eye & Ent Hospital of Fudan University
Shanghai, China, 2000831
3
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, China, 2000892