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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Proliferative Diabetic Retinopathy, Diabetic Macular Edema

Intervention / Treatment
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* Drug: Ranibizumab
* Other: Sham injection
* Procedure: Pars plana vitrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranibizumab<br>Single intravitreal injection of ranibizumab (0.5 mg) 3 7 days before vitrectomy | Drug: Ranibizumab<br>* Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3 7 days before vitrectomy.<br>* Other names: Lucentis;Procedure: Pars plana vitrectomy<br>* Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina<br>* Other names: Vitrectomy;|
| Sham Comparator: Sham injection<br>Sham injection 3 7 days before vitrectomy | Other: Sham injection<br>* Patients will receive single sham injection 3 7 days before vitrectomy.<br>Procedure: Pars plana vitrectomy<br>* Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina<br>* Other names: Vitrectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PDR, DME, ranibizumab, vitrectomy