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

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT04464694

Collaborator

Novartis (Industry)

142

Enrollment

Locations

Arms

Anticipated Duration (Months)

47.3

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Proliferative Diabetic Retinopathy Diabetic Macular Edema	Drug: Ranibizumab Other: Sham injection Procedure: Pars plana vitrectomy	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

142 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Ranibizumab

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

Drug: Ranibizumab

Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3~7 days before vitrectomy.

Other Names:

Lucentis

Procedure: Pars plana vitrectomy

Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina

Other Names:

Vitrectomy

Sham Comparator: Sham injection

Sham injection 3~7 days before vitrectomy

Other: Sham injection

Patients will receive single sham injection 3~7 days before vitrectomy.

Procedure: Pars plana vitrectomy

Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina

Other Names:

Vitrectomy

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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